Ignite Creation Date:
2025-12-24 @ 11:32 PM
Ignite Modification Date:
2025-12-25 @ 9:20 PM
Study NCT ID:
NCT00968656
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D006965', 'term': 'Hyperplasia'}], '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': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-08', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-28', 'lastUpdatePostDateStruct': {'date': '2014-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary out come is to assess the diagnostic quality of [18F]ISO-1-PET/CT images at the proposed 8 mCi dose.', 'timeFrame': '3 years'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome is to quantitatively determine the relationship between tumor [18F]ISO-1 uptake and Ki-67, S-phase, mitotic index and sigma-2 receptors content of the tumor.', 'timeFrame': '3 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Breast cancer', 'Head and Neck Cancer', 'Diffuse Large B-cell lymphoma', 'Cellular proliferation'], 'conditions': ['Breast Cancer', 'Head and Neck Cancer', 'Diffuse Large B-cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to see if Positron Emission Tomography (PET) imaging with a radioactive tracer called 18F-ISO-1 can accurately identify how quickly cancer cells are growing or dividing. A second purpose for this study is to determine, by taking pictures, what tissues and organs of the body take up 18F-ISO-1 naturally and to determine how that uptake changes over time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older with biopsy-proven breast cancer, head \\& neck cancer or diffuse large B-cell lymphoma.\n* For determination of Ki-67, S-phase, mitotic index, and sigma-2 receptor assessment, cancer subjects must be scheduled to undergo surgical resection of the primary tumor without intervening therapy, or be scheduled to undergo (or have already undergone) tissue sampling as either standard of care or part of another research project prior to any planned treatment for their cancer. For tumor sigma-2 receptors assessment, about 0.5 g of fresh tumor tissue kept frozen on dry ice is needed, other proliferative markers may be determined on a much smaller specimen. Thus, it is possible that the analysis of sigma-2 receptors may not be possible in all patients, as obtaining 0.5 g tumor specimen may not practical in all patients.\n* Newly diagnosed breast cancer, head \\& neck cancer, or diffuse large B-cell lymphoma subjects should have a primary lesion size ≥ 1.5 cm as determined by imaging studies (ultrasonography, mammography, CT or MRI) or physical examination and who have not received any treatment for their cancer.\n* Able to give informed consent.\n* Not currently pregnant or nursing: Female subjects must be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), or post menopausal (cessation of menses for more than 1 year). If of childbearing potential, a urine pregnancy test must be performed within the 24 hour period immediately prior to administration of \\[18F\\]ISO-1 and determined to be negative.\n\nExclusion Criteria:\n\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 5 years. Lymphoma patients who have received treatment in the past but have a new diagnosis of diffuse large B-cell lymphoma are eligible to participate providing they will undergo tissue sampling as specified in the inclusion criteria.\n* Unable to tolerate 60-90 minutes of PET imaging.'}, 'identificationModule': {'nctId': 'NCT00968656', 'acronym': 'FISO PET/CT', 'briefTitle': 'Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Assessment of Cellular Proliferation in Tumors by Positron Emission Tomography (PET) Using [18F]ISO-1', 'orgStudyIdInfo': {'id': 'FISO 08-1010'}}, 'armsInterventionsModule': {'interventions': [{'name': 'PET/CT', 'type': 'RADIATION', 'description': 'Patients receive F-18-ISO-1 i.v. and undergo PET/CT imaging at 2-3 time points following the injection.'}, {'name': 'Laboratory Testing', 'type': 'OTHER', 'description': 'Blood and urine samples for laboratory analysis and radioactive counts will be obtained during the imaging sessions'}, {'name': 'Safety Testing', 'type': 'OTHER', 'description': 'ECG tracings, and vital signs (blood pressure, heart rate, body temperature and respiration rate) are obtained at several time points before, during, and after the imaging sessions.'}, {'name': 'Immunohistochemistry staining', 'type': 'OTHER', 'description': 'If available tissue from a biopsy or surgery will be tested cellular proliferation markers such as Ki67 and sigma 2 receptors'}, {'name': 'F-18-ISO', 'type': 'DRUG', 'description': 'Patients receive F-18-ISO-1 i.v.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University / Barnes Jewish Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Farrokh Dehdashti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Isotrace Technologies', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology', 'investigatorFullName': 'Farrokh Dehdashti', 'investigatorAffiliation': 'Washington University School of Medicine'}}}}