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

May 14, 2025 updated by: Memorial Sloan Kettering Cancer Center

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

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Maxine Jochelson, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 24, 2023

Primary Completion (Actual)

April 29, 2024

Study Completion (Actual)

April 29, 2024

Study Registration Dates

First Submitted

November 16, 2023

First Submitted That Met QC Criteria

November 17, 2023

First Posted (Actual)

November 24, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-299

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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