Ignite Creation Date:
2025-12-24 @ 10:37 PM
Ignite Modification Date:
2026-04-09 @ 11:19 PM
Study NCT ID:
NCT01383135
Status:
COMPLETED
Last Update Posted:
2024-01-12
First Post:
2011-05-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D005909', 'term': 'Glioblastoma'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aiagaru@stanford.edu', 'phone': '6507362859', 'title': 'Andrei Iagaru, MD', 'organization': 'Stanford University'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This study is a pilot study.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Healthy Volunteers', 'description': '5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 0, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Breast Cancer Patients', 'description': '4 to 11 mCi F18-FPPRGD2 by IV injection', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Glioblastoma Multiforme', 'description': '5 to14 mCi F18-FPPRGD2 by IV injection', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Lung Cancer', 'description': '5 to14 mCi F18-FPPRGD2 by IV injection', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tracer Dosimetry by Organ', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': '5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection'}], 'classes': [{'title': 'Kidneys', 'categories': [{'measurements': [{'value': '0.3603', 'spread': '0.1852', 'groupId': 'OG000'}]}]}, {'title': 'Liver', 'categories': [{'measurements': [{'value': '0.0988', 'spread': '0.0379', 'groupId': 'OG000'}]}]}, {'title': 'Bladder', 'categories': [{'measurements': [{'value': '0.8615', 'spread': '0.4362', 'groupId': 'OG000'}]}]}, {'title': 'Bowel', 'categories': [{'measurements': [{'value': '0.5290', 'spread': '0.2364', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '5 hours', 'description': 'Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003).\n\nResults are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, data were collected for this outcome from the Healthy Volunteers group only, and only those that completed all scans are included.'}, {'type': 'PRIMARY', 'title': 'F18-FPPRGD2 Time-activity at Specified Timepoints', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Healthy Volunteers', 'description': '5-14 mCi IV F18- FPPRGD2: radiopharmaceutical administered for imaging followed by PET/CT scan'}], 'classes': [{'title': '30 minutes post-injection', 'categories': [{'measurements': [{'value': '26', 'spread': '17', 'groupId': 'OG000'}]}]}, {'title': '60 minutes post-injection', 'categories': [{'measurements': [{'value': '18', 'spread': '14', 'groupId': 'OG000'}]}]}, {'title': '90 minutes post-injection', 'categories': [{'measurements': [{'value': '8', 'spread': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '30, 60, and 90 minutes post-injection', 'description': 'Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time.', 'unitOfMeasure': 'Percentage of tracer remaining in blood', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, data were collected for this outcome from the Healthy Volunteers group only. 4/5 volunteers were able to complete all of the scans. 1/5 participant could only complete one of the four scans and was not included in pharmacokinetic calculations.'}, {'type': 'PRIMARY', 'title': 'Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}, {'units': 'Lesions', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': '4-11 mCi IV F18- FPPRGD2: radiopharmaceutical administered for imaging followed by PET/CT scan'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 hours', 'description': 'Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as \\[TP/ (TP+FN)\\], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result.', 'unitOfMeasure': 'percentage of sensitivity', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Lesions', 'denomUnitsSelected': 'Lesions', 'populationDescription': 'Per protocol, data were collected for this outcome from the Breast Cancer Patients group only. In a per-lesion analysis, a total of 30 lesions were evaluated at PET/CT scanning with F18-FPPRGD2.'}, {'type': 'PRIMARY', 'title': 'Specificity of F18 FPPRGD2 PET/CT in Breast Cancer', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Breast Cancer Patients', 'description': '4-11 mCi IV F18- FPPRGD2: radiopharmaceutical administered for imaging followed by PET/CT scan'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'an estimated average of 3 hours', 'description': 'Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is:\n\n\\[TN/ (TN+FP)\\], where TN= true negative, and FP = false positive.', 'unitOfMeasure': 'percentage of specificity', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, data were collected for this outcome from the Breast Cancer Patients group only. Other cohorts are not included, and the outcome was only assessed in the breast cancer cohort.'}, {'type': 'PRIMARY', 'title': 'Glioblastoma Primary Tumor Response Assessed by PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma Multiforme', 'description': 'F18- FPPRGD2: radiopharmaceutical administered for imaging, up to 14 mCi i.v.'}], 'classes': [{'title': 'Pretreatment', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Week 6', 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '.034', 'groupIds': ['OG000'], 'pValueComment': 'GraphPad (GraphPad Software, San Diego, Calif) was used for the paired two-sample t test and was performed to compare SUVmax values. P \\< .05 was considered to indicate a significant difference', 'groupDescription': 'Comparison made between baseline tumor values and tumor values 6-weeks post-bevacizumab therapy', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER_LEGACY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation.', 'unitOfMeasure': 'SUVmax', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, data were collected for this outcome from the Glioblastoma Multiforme group only. Participants in the Glioblastoma Multiforme group who completed the imaging schedule were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Glioblastoma Primary Tumor Response Assessed by CT Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Glioblastoma Multiforme', 'description': 'F18-FPPRGD2: radiopharmaceutical administered for imaging, up to 14 mCi IV'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.0', 'spread': '80.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 6', 'description': 'Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by computed tomography (CT) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the mean difference from baseline to week 6, with standard deviation.', 'unitOfMeasure': 'percentage change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol, data were collected for this outcome from the Glioblastoma Multiforme group only. Participants in the Glioblastoma Multiforme group who completed the imaging schedule were included in the analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Healthy Volunteers', 'description': '5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.'}, {'id': 'FG001', 'title': 'Breast Cancer', 'description': '4 to 11 mCi F18-FPPRGD2 by IV injection'}, {'id': 'FG002', 'title': 'Glioblastoma Multiform Patients', 'description': '5 to14 mCi F18-FPPRGD2 by IV injection'}, {'id': 'FG003', 'title': 'Lung Cancer', 'description': 'X to XX mCi F18-FPPRGD2 by IV injection'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Not Scanned / Imaged', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '27', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Healthy Volunteers', 'description': '5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection'}, {'id': 'BG001', 'title': 'Breast Cancer Patients', 'description': '4 to 11 mCi F18-FPPRGD2 by IV injection'}, {'id': 'BG002', 'title': 'Glioblastoma Multiforme', 'description': '5 to14 mCi F18-FPPRGD2 by IV injection'}, {'id': 'BG003', 'title': 'Lung Cancer', 'description': 'X to XX mCi F18-FPPRGD2 by IV injection'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '19', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-14', 'studyFirstSubmitDate': '2011-05-31', 'resultsFirstSubmitDate': '2017-02-05', 'studyFirstSubmitQcDate': '2011-06-24', 'lastUpdatePostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-14', 'studyFirstPostDateStruct': {'date': '2011-06-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2024-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tracer Dosimetry by Organ', 'timeFrame': '5 hours', 'description': 'Normal radiopharmaceutical biodistribution was analyzed visually to obtain dosimetry data in healthy volunteers. Organs with the highest radiation absorbed dose (dosimetry) are provided below. Dosimetry was calculated by drawing regions-of-interest around organs with visually appreciable radiopharmaceutical uptake greater than background and using organ-level internal dose assessment software from Vanderbuilt University (2003).\n\nResults are reported in mSv/MBq (milli-Sieverts per mega-Bequerel) which is a measurement of the mean absorbed radiation dose within an organ.'}, {'measure': 'F18-FPPRGD2 Time-activity at Specified Timepoints', 'timeFrame': '30, 60, and 90 minutes post-injection', 'description': 'Radiopharmaceutical pharmacokinetics describe the change in radiopharmaceutical distribution in the body (from the blood to organs, tissues, cells) over time. Radiopharmaceutical pharmacokinetics are used to determine optimal imaging time, ie, when target activity (organ or cell of interest) is greater than background activity (blood). Optimal imaging time must also be balanced with tracer bio-metabolism and radioactive decay. F18-FPPRGD2 pharmacokinetics was measured in healthy volunteers to estimate optimal imaging time. Scans were used to visually identify regions of interest (organs of F18-FPPRGD2 accumulation), and detected radiation was plotted as a measurement over time.'}, {'measure': 'Sensitivity of F18-FPPRGD2 PET/CT in Breast Cancer', 'timeFrame': '3 hours', 'description': 'Sensitivity is the ability of a test to correctly identify patients with the disease being investigated. In this instance, how well F18-FPPRGD2 PET/CT detects true-positive patients. Sensitivity is defined as \\[TP/ (TP+FN)\\], where TP= true positive, and FN = false negative. The outcome is reported as a percentage without dispersion. A higher percentage indicates a greater probability that a lesion identified based on scan results is cancerous, and a lower percentage indicates reduced confidence in that result.'}, {'measure': 'Specificity of F18 FPPRGD2 PET/CT in Breast Cancer', 'timeFrame': 'an estimated average of 3 hours', 'description': 'Specificity is the ability of a test to correctly identify patients who do not have the disease being investigated. In this instance, how well F18 FPPRGD2 PET/CT detects true-negative patients. Specificity is:\n\n\\[TN/ (TN+FP)\\], where TN= true negative, and FP = false positive.'}, {'measure': 'Glioblastoma Primary Tumor Response Assessed by PET Scan', 'timeFrame': 'Baseline and Week 6', 'description': 'Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by positron emission tomography (PET) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the baseline and week 6 values, with standard deviation.'}], 'secondaryOutcomes': [{'measure': 'Glioblastoma Primary Tumor Response Assessed by CT Scan', 'timeFrame': 'Baseline and Week 6', 'description': 'Primary tumor response was assessed after 6 weeks of treatment as the change in tumor metabolism based on the maximum standardized uptake value (SUVmax) as determined by computed tomography (CT) scans. Decreased SUVmax correlates to a reduction of tumor metabolism, and is considered an indicator of primary tumor response. Reduction of SUVmax was determined as the change from baseline in uptake of F-18FPPRGD2. The outcome is reported as the mean difference from baseline to week 6, with standard deviation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Breast Cancer', 'Non-Small-Cell Lung Cancer', 'Glioblastoma', 'Other Cancers']}, 'descriptionModule': {'briefSummary': 'The purpose of the study was to conduct a pilot test of new tracers (\\[18F\\]FPRGD2 and \\[18F\\]FPPRGD2) to define normal tracer biodistribution (where the tracer goes), stability (how much metabolises), pharmacokinetics (how much stays in which organs and for how long), and radiation dosimetry (organ radiation dose). Healthy volunteers provided the normal biodistribution data.\n\nThe same radiopharmaceutical was also tested in breast cancer, glioblastoma multiform (brain cancer), and lung cancer.', 'detailedDescription': 'The tracer \\[18F\\]FPRGD2 was not evaluated in this study. The protocol title was never amended to reflect this.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHealthy volunteers:\n\n1. Must be 18 years of age or older.\n2. Must have no known medical problems and have had a full medical exam within 6 months of the study.\n3. Must understand and voluntarily have signed an Informed Consent after its contents have been fully explained.\n4. Women of child bearing potential (as defined as women who are not post menopausal for 12 months or who have had no previous surgical sterilization).\n5. Men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and for 30 days after the last dose.\n\nCancer subjects:\n\n1. Greater than 18 years-old at the time of radiotracer administration\n2. Provides written informed consent\n3. Diagnosed with advanced non-small cell lung cancer (NSCLC), breast cancer, pancreatic cancer and glioblastoma multiforme (GBM); patients will undergo bevacizumab or Cyberknife therapy\n4. Able to remain still for duration of each imaging procedure (about one hour)\n\nExclusion Criteria\n\n1. Less than 18 years-old at the time of radiotracer administration\n2. Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01383135', 'briefTitle': 'Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Biodistribution and Safety of the PET Probes [18F]FPRGD2 and [18F]FPPRGD2', 'orgStudyIdInfo': {'id': 'IRB-16118'}, 'secondaryIdInfos': [{'id': 'SU-09022010-6791', 'type': 'OTHER', 'domain': 'Stanford University'}, {'id': 'VAR0047', 'type': 'OTHER', 'domain': 'OnCore Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Healty Volunteers', 'description': 'Normal volunteers to receive 5 to 14 mCi F18-FPPRGD2 by intravenous (IV) injection.', 'interventionNames': ['Drug: F18-FPPRGD2']}, {'type': 'EXPERIMENTAL', 'label': 'Breast Cancer', 'description': 'Breast cancer patients to receive 4 to 11 mCi F18-FPPRGD2 by IV injection.', 'interventionNames': ['Drug: F18-FPPRGD2']}, {'type': 'EXPERIMENTAL', 'label': 'Glioblastoma Multiform (brain)', 'description': 'Glioblastoma multiform patients to receive 5 to14 mCi F18-FPPRGD2 by IV injection.', 'interventionNames': ['Drug: F18-FPPRGD2']}, {'type': 'EXPERIMENTAL', 'label': 'Lung Cancer', 'description': 'Lung cancer patients to receive X to XX mCi F18-FPPRGD2 by IV injection.', 'interventionNames': ['Drug: F18-FPPRGD2']}], 'interventions': [{'name': 'F18-FPPRGD2', 'type': 'DRUG', 'description': 'Radiopharmaceutical administered for imaging, up to 14 mCi intravenous (IV).', 'armGroupLabels': ['Breast Cancer', 'Glioblastoma Multiform (brain)', 'Healty Volunteers', 'Lung Cancer']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Sanjiv Gambhir, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}