Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-01-01 @ 11:11 AM
Study NCT ID:
NCT03542695
Status:
COMPLETED
Last Update Posted:
2024-06-24
First Post:
2018-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D002114', 'term': 'Calcinosis'}], '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': 'D002128', 'term': 'Calcium Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000071184', 'term': 'Pharmacogenomic Variants'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D011110', 'term': 'Polymorphism, Genetic'}, {'id': 'D014644', 'term': 'Genetic Variation'}, {'id': 'D055614', 'term': 'Genetic Phenomena'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-21', 'studyFirstSubmitDate': '2018-05-18', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2024-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum standardized uptake value (SUVmax) of 64Cu-DOTA-alendronate in evaluating tumor size and calcifications', 'timeFrame': 'Up to 7 days', 'description': 'Tumor size sensitivity and the ability to detect calcifications will be compared to the extent of calcifications seen on mammogram.'}], 'secondaryOutcomes': [{'measure': 'Uptake of 64Cu-DOTA-alendronate on positron emission tomography (PET) scan compared to histology after mastectomy', 'timeFrame': 'Up to 7 days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Breast Carcinoma', 'Calcification']}, 'descriptionModule': {'briefSummary': 'This early phase I pilot trial studies how well 64Cu-DOTA-alendronate positron emission tomography (PET) imaging work in localizing and characterizing breast calcifications (small calcium deposits) in participants before undergoing mastectomy. Diagnostic procedures, such 64Cu-DOTA-alendronate PET, may detect calcification and help doctors predict cancer associated calcification within breast tissue.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To evaluate the uptake (maximum standardized uptake value \\[SUVmax\\]) of 64Cu-DOTA-alendronate in female patients with biopsy-proven malignant breast calcifications.\n\nSECONDARY OBJECTIVES:\n\nI. To compare uptake of 64Cu-DOTA-alendronate on PET -computed tomography (CT) with histology after mastectomy.\n\nOUTLINE: This is a dose-escalation study of 64Cu-DOTA-alendronate.\n\nParticipants receive 64Cu-DOTA-alendronate intravenously (IV) and undergo PET/CT imaging 60 minutes after injection. Participants with sufficient levels of residual radioactivity may undergo repeat imaging on day 1 as determined by the study team.\n\nAfter completion of study , participants are followed up for 7 days.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Evidence of calcifications on mammogram\n* Biopsy confirmed malignancy associated calcifications in at least one breast\n* Biopsy confirmed benign calcifications in at least one breast (same or contralateral breast)\n* Planned total mastectomy for treatment\n* Ability to provide informed consent\n* Negative serum pregnancy test\n* No evidence of impaired hepatic or kidney function\n\nExclusion Criteria:\n\n* Participants who do not have residual calcifications present on mammogram following biopsy\n* Concurrent malignancy other than non-melanoma skin cancer\n* Patients with known metastatic disease\n* Patients who have received prior treatment for the current breast cancer\n* Patients currently using oral bisphosphonate therapy\n* Patients with injection of other radioactive material within 90 days\n* Inability to provide informed consent\n* Pregnant or lactating patients\n* Patients with impaired kidney function (creatinine \\>= 1.3 mg/dL or \\< 0.6 mg/dL)'}, 'identificationModule': {'nctId': 'NCT03542695', 'briefTitle': '64 Cu-DOTA-alendronate PET Imaging in Localizing and Characterizing Breast Calcifications in Participants Before Undergoing Mastectomy', 'organization': {'class': 'OTHER', 'fullName': 'City of Hope Medical Center'}, 'officialTitle': 'Use of 64Cu-DOTA-Alendronate PET Imaging for Localization and Characterization of Breast Calcifications', 'orgStudyIdInfo': {'id': '18112'}, 'secondaryIdInfos': [{'id': 'NCI-2018-00890', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '18112', 'type': 'OTHER', 'domain': 'City of Hope Medical Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)', 'description': 'Participants receive 64Cu-DOTA-alendronate IV and undergo PET/CT imaging 60 minutes after injection. Participants with sufficient levels of residual radioactivity may undergo repeat imaging on day 1 as determined by the study team.', 'interventionNames': ['Procedure: Computed Tomography', 'Drug: Copper Cu-64-DOTA-alendronate', 'Other: Pharmacokinetic Study', 'Procedure: Positron Emission Tomography']}], 'interventions': [{'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'computerized tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo PET/CT', 'armGroupLabels': ['Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)']}, {'name': 'Copper Cu-64-DOTA-alendronate', 'type': 'DRUG', 'otherNames': ['64Cu-DOTA-alendronate; [64Cu]-DOTA-alendronate'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)']}, {'name': 'Pharmacokinetic Study', 'type': 'OTHER', 'otherNames': ['PHARMACOKINETIC', 'PK Study'], 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET Scan', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo PET/CT', 'armGroupLabels': ['Diagnostic (64Cu-DOTA-alendronate, PET/CT scan)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}], 'overallOfficials': [{'name': 'Veronica Jones, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'City of Hope Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'City of Hope Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}