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

Early Phase 1

Withdrawn

• Conditions: Breast Cancer; Metastatic Breast Cancer; Female Breast Cancer; Breast Carcinoma; Metastatic Breast Carcinoma
• Interventions: Diagnostic Test: 18F-FDG PET/CT; Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging; Drug: 18F-FDHT

• Registration Number: NCT06145399
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-24
• Study First Submitted: 2023-11-16
• Study First Submitted QC: 2023-11-17
• Study First Posted: 2023-11-24
• Primary Completion: 2024-04-29
• Study Completion: 2024-04-29
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-18

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participants with Breast Cancer	18F-FDHT	Participants with histologically confirmed AR+ breast cancer
Participants with Breast Cancer	18F-FDG PET/CT	Participants with histologically confirmed AR+ breast cancer
Participants with Breast Cancer	[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging	Participants with histologically confirmed AR+ breast cancer

Primary Outcome Measures

Name	Time	Method
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.