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

NCT ID: NCT06145399

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

EARLY_PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2024-04-29

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Participants with Breast Cancer

Participants with histologically confirmed AR+ breast cancer

Group Type EXPERIMENTAL

18F-FDG PET/CT

Intervention Type DIAGNOSTIC_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 Imaging

Intervention Type DIAGNOSTIC_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-FDHT

Intervention Type DRUG

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.

Interventions

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18F-FDG PET/CT

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

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DRUG

Other Intervention Names

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18F- FDHT PET/MRI examinations [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maxine Jochelson, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Related Links

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http://www.mskcc.org

Memorial Sloan Kettering Cancer Center

Other Identifiers

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21-299

Identifier Type: -

Identifier Source: org_study_id

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