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NCT06145399 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT06145399
Other study ID # 21-299
Secondary ID
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date October 24, 2023
Est. completion date April 29, 2024

Study information
Verified date April 2024
Source Memorial Sloan Kettering Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 29, 2024
Est. primary completion date April 29, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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
• [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.
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.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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