Breast Cancer, Breast Carcinoma, Female Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Carcinoma
Conditions
Keywords
Breast Cancer, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, AR+ breast cancer, Progressive metastatic breast cancer, 21-299, Memorial Sloan Kettering Cancer Center, Female Breast Cancer
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.
Interventions
DIAGNOSTIC_TEST18F-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.
DRUG18F-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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR | 8 weeks post treatment | The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions. |
Outcome results
None listed