NCT06145399
Withdrawn
Early Phase 1
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
ConditionsBreast CancerBreast CarcinomaMetastatic Breast CancerMetastatic Breast CarcinomaFemale Breast Cancer
Interventions18F-FDG PET/CT[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging18F-FDHT
Drugs18F-FDHT
Overview
- Phase
- Early Phase 1
- Intervention
- 18F-FDG PET/CT
- Conditions
- Breast Cancer
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary Endpoint
- Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
- Status
- Withdrawn
- Last Updated
- 11 months ago
Overview
Brief Summary
The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age ≥ 18 years
- •ECOG performance score of 0-2
- •Signed informed consent
- •Histologically confirmed AR+ breast cancer
- •All participants under consideration for enrollment will have their tumor specimen tested centrally at MSK; nuclear AR staining ≥ 1% will be considered positive.
- •Progressive metastatic breast cancer manifested as increase in evaluable disease OR the appearance of new sites of disease since the date of the last imaging study performed and under consideration for AR-targeted therapy
- •Planning to undergo treatment with agents targeting the antiandrogen signaling pathway on a clinical trial
Exclusion Criteria
- •Life expectancy \< 3 months
- •Pregnancy or lactation
- •Participants who cannot undergo scanning because of
- •weight limits
- •devices or implants that are not MRI safe
- •allergies to contrast materials
- •CNS only disease on recent imaging
Arms & Interventions
Participants with Breast Cancer
Participants with histologically confirmed AR+ breast cancer
Intervention: 18F-FDG PET/CT
Participants with Breast Cancer
Participants with histologically confirmed AR+ breast cancer
Intervention: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging
Participants with Breast Cancer
Participants with histologically confirmed AR+ breast cancer
Intervention: 18F-FDHT
Outcomes
Primary Outcomes
Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
Time Frame: 8 weeks post treatment
The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions.
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