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No accruals
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with Breast Cancer | Experimental | Participants with histologically confirmed AR+ breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FDG PET/CT | Diagnostic Test | Standard-of-care 18F-FDG PET/CT will be performed using one of the commercially available GE PET/CT scanners |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Age ≥ 18 years
ECOG performance score of 0-2
Signed informed consent
Histologically confirmed AR+ breast cancer
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
CNS only disease on recent imaging
All participants recruited to the protocol will be women, as breast cancer is primarily a disease of women
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| Name | Affiliation | Role |
|---|---|---|
| Maxine Jochelson, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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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.
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| [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging | 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 | 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. |
|
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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