Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT01018251
Status:
WITHDRAWN
Last Update Posted:
2015-12-15
First Post:
2009-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'interventionBrowseModule': {'meshes': [{'id': 'C002854', 'term': 'alovudine'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2009-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2009-11-18', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and specificity of FLT-PET comparing with standard FDG-PET'}, {'measure': 'Correlate SUV with % Ki67 nuclear stain'}], 'secondaryOutcomes': [{'measure': 'Change in SUV with change in tumor proliferation index (%Ki67 nuclear stain) (when neoadjuvant therapy is used)'}, {'measure': 'Tumor volume pre and post chemotherapy as assessed by clinical exam, breast imaging studies, histopathological examination, and breast cancer outcome parameters (when neoadjuvant therapy is used)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adult Women With a New Diagnosis of Invasive Breast Cancer (Have Not Undergone Treatment)']}, 'descriptionModule': {'briefSummary': 'This study will investigate the sensitivity and specificity of FLT-PET/CT in primary breast cancer detection and in the use of FLT-PET in monitoring how well a breast tumor respond to treatment. We will compare this technique with other imaging modalities as well as with tissue collection (during a biopsy). We will recruit women with a newly diagnosed invasive breast cancer, who are able to tolerate undergoing a PET/CT (possibly two scans) scan,', 'detailedDescription': 'Our overall goal is to use this clinical trial as a platform to validate fibroblast activation protein (FAP) as a biomarker for the tumor microenvironment and to explore the dynamic interaction between proliferating tumor cells and the tumor microenvironment. Our long term goal is to develop new drugs that will target the tumor microenvironment as novel therapeutic and chemoprevention strategies.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Breast biopsy positive for an invasive malignancy (core needle, mammatone, or incisional biopsy)\n* Participants must be planning to have surgery at the Hospital of the University of Pennsylvania\n* Participants must be able to tolerating lying on the table for about an hour\n* Newly diagnosed primary breast cancer, which is classified as being operable (T1-T4)\n\nExclusion Criteria:\n\n* Pregnant women\n* History of severe renal disease\n* Prior history of breast cancer of the study breast within the last five years.'}, 'identificationModule': {'nctId': 'NCT01018251', 'briefTitle': 'Positron Emission Tomography in Monitoring Treatment Response in Women With Newly Diagnosed Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'Monitoring Treatment Response in Women With Breast Cancer Utilizing FLT-PET/CT', 'orgStudyIdInfo': {'id': 'UPCC 01109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': "Patients undergoing definitive surgery after cancer diagnosis undergo 3'-deoxy-3'-\\[18F\\] fluorothymidine (FLT)-PET prior to definitive surgery. Patients undergoing neoadjuvant chemotherapy prior to definitive surgery undergo FLT-PET prior to and after completion of neoadjuvant chemotherapy", 'interventionNames': ["Other: 3'-deoxy-3'-[18F]fluorothymidine", 'Procedure: Positron Emission Tomography/computed tomography', 'Radiation: FLT-PET/CT']}], 'interventions': [{'name': "3'-deoxy-3'-[18F]fluorothymidine", 'type': 'OTHER', 'otherNames': ['18F-FLT'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}, {'name': 'Positron Emission Tomography/computed tomography', 'type': 'PROCEDURE', 'armGroupLabels': ['Arm I']}, {'name': 'FLT-PET/CT', 'type': 'RADIATION', 'armGroupLabels': ['Arm I']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Julia Tchou, MD', 'oldOrganization': 'Abramson Cancer Center of the University of Pennsylvania'}}}}