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

Early Phase 1WithdrawnNCT06145399

Memorial Sloan Kettering Cancer Center

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Conditions

Breast Cancer Breast Carcinoma Metastatic Breast Cancer Metastatic Breast Carcinoma Female Breast Cancer

Interventions

18F-FDG PET/CTDIAGNOSTIC_TEST

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

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

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.

18F-FDHTDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks post treatment

Data from ClinicalTrials.gov

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