A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer
NCT ID: NCT06145399
Last Updated: 2025-05-18
Study Results
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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WITHDRAWN
EARLY_PHASE1
INTERVENTIONAL
2023-10-24
2024-04-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Participants with Breast Cancer
Participants with histologically confirmed AR+ breast cancer
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.
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.
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
[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.
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Maxine Jochelson, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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21-299
Identifier Type: -
Identifier Source: org_study_id
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