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

Memorial Sloan Kettering Cancer Center (MSK)

Status and phase: Withdrawn; Early Phase 1

Conditions: Breast Cancer; Metastatic Breast Carcinoma; Female Breast Cancer; Metastatic Breast Cancer; Breast Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06145399

21-299

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: No 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

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Participants with Breast Cancer

Experimental group

Description:

Participants with histologically confirmed AR+ breast cancer

Treatment:

Diagnostic Test: 18F-FDG PET/CT

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

Drug: 18F-FDHT