A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer

Study Overview
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Brief Summary
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The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.

Official Title
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[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer

Conditions
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Breast Cancer, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, Female Breast Cancer

Intervention / Treatment
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* Diagnostic Test: 18F-FDG PET/CT
* Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging
* Drug: 18F-FDHT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with Breast Cancer<br>Participants with histologically confirmed AR+ breast cancer | Diagnostic Test: 18F-FDG PET/CT<br>* Standard-of-care 18F-FDG PET/CT will be performed using one of the commercially available GE PET/CT scanners<br>Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging<br>* 18F- FDHT PET/MRI examinations will be performed to evaluate the association between 18F-FDHT uptake and AR expression levels as determined by immunohistochemistry (IHC) in selected lesions.<br>* Other names: 18F- FDHT PET/MRI examinations;Drug: 18F-FDHT<br>* 18F- FDHT PET/MRI examinations will be performed to evaluate the association between 18F-FDHT uptake and AR expression levels as determined by immunohistochemistry (IHC) in selected lesions.<br>* Other names: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR | The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions. | 8 weeks post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, AR+ breast cancer, Progressive metastatic breast cancer, 21-299, Memorial Sloan Kettering Cancer Center, Female Breast Cancer