Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01159405
Status:
UNKNOWN
Last Update Posted:
2014-07-30
First Post:
2010-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006020', 'term': 'Glycopeptides'}], 'ancestors': [{'id': 'D006001', 'term': 'Glycoconjugates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-07-29', 'studyFirstSubmitDate': '2010-07-08', 'studyFirstSubmitQcDate': '2010-07-08', 'lastUpdatePostDateStruct': {'date': '2014-07-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the best dose of 99mTc-GP in imaging based upon safety data and tumor-to background (T/B) count density ratios.', 'timeFrame': 'from 99mTc-GP injection through 30 days'}], 'secondaryOutcomes': [{'measure': 'To determine the optimal time to imaging after injection of 99mTc-GP based upon tumor to-background (T/B) count density ratios at various times.', 'timeFrame': 'from 99mTc-GP injection through 30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the biodistribution and dosimetry of single dose of 99mTc-glycopeptide (99mTc-GP, 20-25 mCi) in 3 different doses of GP (5, 10and 20 mg)in patients with breast cancer at pre-chemotherapy.', 'detailedDescription': 'Cohorts of 3 will be treated each at different dose levels and images will be taken at 4 time points. For dosimetry estimates, there will be a 20-24 hr time point post-administration of 99mTc-GP for the first 3 patients. If the biodistribution and dosimetry can be adequately quantified without the 20-24 hr scan in 3 patients, then we will eliminate that 4th scan for all other patients. Urine and blood samples will be collected at 5 time points, and an additional blood and urine sample will be collected for dosimetry analysis at 30\\~60 min.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with newly diagnosed stage I-IV breast cancer (tumor size\n\n * 2cm in imaging examinations) who are scheduled to start systemic therapy.\n* Patients must have histological diagnosis of invasive breast cancer.\n* Extent of disease will be determined by physical examination and conventional radiological studies.\n* Must be age 18 or older.\n* ECOG performance status 0-2.\n* Patients with history of prior malignancies must be disease-free for at least 5 years of study entry.\n* Normal hematological function: WBC \\> 3000/ul, absolute neutrophil count \\> 1500/ul, platelets \\> 100,000/ul, and Hgb \\> 10 gms (transfusion to achieve Hgb \\> 10 gms is acceptable).\n* Serum total bilirubin \\< 1.5 mg/dl and SGPT \\< 1.5 X normal.\n* Adequate kidney function (creatinine \\< 1.5 mg/dL).\n\nExclusion Criteria:\n\n* Patients who received previous chemotherapy for the newly diagnosed breast cancer.\n* No evidence of primary breast lesion (e.g. T0, Tx).\n* Pregnant women or sexually active women of childbearing potential who are not practicing adequate contraception are excluded.\n* Patients with myocardial infarction within 6 months of study entry; unstable angina pectoris; uncontrolled congestive heart failure; uncontrolled arrhythmia are excluded.\n* Patients with history of hypersensitivity/allergy to Chitosan/Chitin related shellfish foods.'}, 'identificationModule': {'nctId': 'NCT01159405', 'briefTitle': 'The Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide(99mTc-GP) in Patients With Breast Cancer', 'nctIdAliases': ['NCT01374529'], 'organization': {'class': 'INDUSTRY', 'fullName': 'SeeCure LLC'}, 'officialTitle': 'A Pilot Study of Biodistribution and Dosimetry of 99mTc-Glycopeptide (99mTc-GP) in Patients With Breast Cancer', 'orgStudyIdInfo': {'id': 'SeeCure GP-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '99mTc-GP', 'description': '99mTc-GP with SPECT/CT imaging \\& whole body scan.', 'interventionNames': ['Radiation: Radiolabeled (99mTc) GP (Glycopeptide)']}], 'interventions': [{'name': 'Radiolabeled (99mTc) GP (Glycopeptide)', 'type': 'RADIATION', 'description': 'one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg \\& 20 mg of GP will be injected', 'armGroupLabels': ['99mTc-GP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Eileen Dickman, PhD, MBA, CCRC', 'role': 'CONTACT', 'email': 'edickman@houstonmethodist.org', 'phone': '713-441-9777'}, {'name': 'Andrea Dotting, M.D', 'role': 'CONTACT', 'email': 'andotting@houstonmethodist.org', 'phone': '713-441-8029'}, {'name': 'Tejal Patel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Angel Rodriguez, M.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Y. Lee, M.D., Ph.D.', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jenny C-N Chang, M.B.BChir, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Ning Tsao, PhD', 'role': 'CONTACT', 'email': 'ning.tsao@seecurellc.com', 'phone': '7135719410'}, {'name': 'Chung Wei Huang, Master', 'role': 'CONTACT', 'email': 'huangchungwei@seecurellc.com', 'phone': '7135719410'}], 'overallOfficials': [{'name': 'Tejal Patel, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Breast Medical Oncologist, Methodist Cancer Center, Houston, Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SeeCure LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}