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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT06145399

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Breast Carcinoma Metastatic Breast Cancer Metastatic Breast Carcinoma Female Breast Cancer	Diagnostic Test: 18F-FDG PET/CT Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging Drug: 18F-FDHT	Early Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 24, 2023

Anticipated Primary Completion Date :

Oct 24, 2026

Anticipated Study Completion Date :

Oct 24, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Participants with Breast Cancer Participants with histologically confirmed AR+ breast cancer	Diagnostic Test: 18F-FDG PET/CT Standard-of-care 18F-FDG PET/CT will be performed using one of the commercially available GE PET/CT scanners Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging 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. Other Names: 18F- FDHT PET/MRI examinations Drug: 18F-FDHT 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. Other Names: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

Arm

Intervention/Treatment

Experimental: Participants with Breast Cancer

Participants with histologically confirmed AR+ breast cancer

Diagnostic Test: 18F-FDG PET/CT

Standard-of-care 18F-FDG PET/CT will be performed using one of the commercially available GE PET/CT scanners

Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging

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.

Other Names:

18F- FDHT PET/MRI examinations

Drug: 18F-FDHT

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.

Other Names:

[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

Outcome Measures

Primary Outcome Measures

Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR [8 weeks post treatment]
The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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