Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-27 @ 11:14 PM
Study NCT ID:
NCT05880394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-12
First Post:
2023-02-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Dotatate Imaging in 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-08', 'studyFirstSubmitDate': '2023-02-24', 'studyFirstSubmitQcDate': '2023-05-26', 'lastUpdatePostDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uptake of Ga-68-DOTATATE or Copper-64 DOTATATE using Krenning Score and standardized uptake value (SUV)', 'timeFrame': '6 months'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Cancer Stage IV']}, 'descriptionModule': {'briefSummary': 'This will be a Phase 2 clinical trial to assess somatostatin receptor (SSTR) expression in Stage IV estrogen receptor positive (ER+) breast cancer using Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT.', 'detailedDescription': 'Subjects with metastatic breast cancer are planned to be enrolled to undergo Gallium-68 DOTATATE or Copper-64 DOTATATE PET/CT imaging at one time point. SSTR uptake in metastatic lesions will be evaluated by independent central review (ICR). FDG PET and bone scans will also be performed within +/- 3 weeks of DOTATATE imaging.\n\nThe primary objective of this study is to evaluate uptake of Gallium-68 DOTATATE or Copper-64 DOTATATE in metastatic ER+ breast cancer lesions.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age of at least 18 years at the time of signing the informed consent.\n* Biopsy proven, ER+, HER2 any, clinically progressive, Stage IV breast cancer requiring restaging.\n* For women of childbearing potential (WOCBP):\n\n a. Negative serum pregnancy test within 48 hours of Ga-68-DOTATATE injection. A women is considered to be of childbearing potential if she is post-menarchal, has not reached postmenopausal state (≥ 12 continuous months of amenorrhea \\[no menstrual bleeding of any kind, including menstrual period, irregular bleeding, spotting, etc.\\] with no identified cause other than menopause), and has not undergone surgical sterilization (total hysterectomy, or bilateral tubal ligation or bilateral oophorectomy at least 6 weeks before taking study drug).\n* Willingness and ability to provide written informed consent prior to any study-specific assessments and procedures commence.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Gallium-68 DOTATATE or Copper-64 DOTATATE, octreotate, or any of the excipients of Gallium-68 DOTATATE or Copper-64 DOTATATE\n* Current high-dose glucocorticoid (≥ 20 mg prednisone daily or equivalent); long acting SSA within the last 28 days; short acting SSA that cannot be interrupted for 24 hours.\n* Unable to perform PET/CT scans according to technical specifications and local guidelines.\n* Concurrent primary malignancy, except adequately treated carcinoma in situ, non-melanoma carcinoma of the skin or any other curatively treated malignancy that has achieved complete response and is not expected to require treatment for recurrence during participation in the study.\n* Current somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.\n* Unable or unwilling to comply with the requirements of the study protocol.\n* Prior participation in any interventional clinical study within 30 days prior to SSTR PET/CT scan.'}, 'identificationModule': {'nctId': 'NCT05880394', 'briefTitle': 'Study of Dotatate Imaging in Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Hoag Memorial Hospital Presbyterian'}, 'officialTitle': 'Somatostatin Receptor Imaging Study of Estrogen Receptor Positive (ER+) Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '163-22-CA'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Gallium-68 DOTATATE', 'type': 'DRUG', 'description': 'Gallium-68 DOTATATE is a diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor expression on tumors.'}, {'name': 'Copper-64 DOTATATE', 'type': 'DRUG', 'description': 'Copper-64 DOTATATE is a diagnostic agent for use with positron emission tomography (PET) for localization of somatostatin receptor expression on tumors.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92614', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}], 'overallOfficials': [{'name': 'Gary Ulaner, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hoag Memorial Hospital Presbyterian'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoag Memorial Hospital Presbyterian', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Molecular Imaging and Therapy, Hoag Family Cancer Institute', 'investigatorFullName': 'Gary Ulaner', 'investigatorAffiliation': 'Hoag Memorial Hospital Presbyterian'}}}}