NCT06145399

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2023

Shorter than P25 for early_phase_1 breast-cancer

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 24, 2023

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 24, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2024

Completed
Last Updated

May 18, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

November 16, 2023

Last Update Submit

May 14, 2025

Conditions

Breast CancerBreast CarcinomaMetastatic Breast CancerMetastatic Breast CarcinomaFemale Breast Cancer

Keywords

Breast CancerBreast CarcinomaMetastatic Breast CancerMetastatic Breast CarcinomaAR+ breast cancerProgressive metastatic breast cancer21-299Memorial Sloan Kettering Cancer CenterFemale Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 weeks post treatment

Study Arms (1)

Participants with Breast Cancer

EXPERIMENTAL

Participants with histologically confirmed AR+ breast cancer

Diagnostic Test: 18F-FDG PET/CTDiagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET ImagingDrug: 18F-FDHT

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

Participants with Breast Cancer
[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.

Also known as: 18F- FDHT PET/MRI examinations
Participants with Breast Cancer
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.

Also known as: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
Participants with Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAll participants recruited to the protocol will be women, as breast cancer is primarily a disease of women
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Maxine Jochelson, MD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2023

First Posted

November 24, 2023

Study Start

October 24, 2023

Primary Completion

April 29, 2024

Study Completion

April 29, 2024

Last Updated

May 18, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

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.