Breast CancerEarly Phase 1NCT06145399
A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer
A Early Phase 1 study testing 18F-FDG PET/CT, [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging and 18F-FDHT in people with Breast Cancer and Breast Carcinoma, run by Memorial Sloan Kettering Cancer Center.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Carcinoma, Metastatic Breast Cancer
- What is being tested?
- 18F-FDG PET/CT, [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging and 18F-FDHT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 24 Oct 2023to 29 Apr 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.
- Conditions
- Breast Cancer, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, Female Breast Cancer
- Being tested
- 18F-FDG PET/CT, [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging, 18F-FDHT
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FDG PET/CTDiagnostic 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 ImagingDiagnostic test
Also called 18F- FDHT PET/MRI examinations
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-FDHTDrug
Also called [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone
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.
| Study group | Role | What they receive |
|---|---|---|
| Participants with Breast Cancer | Experimental | Participants with histologically confirmed AR+ breast cancer Receives: Diagnostic Test: 18F-FDG PET/CT; Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging; Drug: 18F-FDHT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2023
- Study start24 Oct 2023
- Primary completion29 Apr 2024
- Study completion29 Apr 2024
Why it stopped: No accruals
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maxine Jochelson, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145399
- Sponsor's protocol ID
- 21-299
- Status last verified
- May 2025
- First submitted
- 16 Nov 2023
- Last updated
- 18 May 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT06145399
- Acronym / sponsor ID
- 21-299
- Conditions
- Breast Cancer, Breast Carcinoma, Metastatic Breast Cancer, Metastatic Breast Carcinoma, Female Breast Cancer
- 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
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No accruals
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- 29 Apr 2024 (actual)
- Study completion
- 29 Apr 2024 (actual)
- First posted
- 24 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to see whether 18F-FDHT PET/MRI scans are an effective way of identifying AR-positive breast cancer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Breast Cancer | Experimental | Diagnostic Test: 18F-FDG PET/CT, Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging, Drug: 18F-FDHTParticipants with histologically confirmed AR+ breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- Life expectancy < 3 months
- Pregnancy or lactation
- Participants who cannot undergo scanning because of
- CNS only disease on recent imaging
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 18F-FDG PET/CTStandard-of-care 18F-FDG PET/CT will be performed using one of the commercially available GE PET/CT scanners | Diagnostic test | Participants with Breast Cancer |
| [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET ImagingAlso: 18F- FDHT PET/MRI examinations18F- 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. | Diagnostic test | Participants with Breast Cancer |
| 18F-FDHTAlso: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone18F- 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 | Participants with Breast Cancer |
Primary outcome
Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
Time frame: 8 weeks post treatment
The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maxine Jochelson, MD principal investigator
Memorial Sloan Kettering Cancer Center
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing 18F-FDG PET/CT, [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging and 18F-FDHT in people with Breast Cancer and Breast Carcinoma, run by Memorial Sloan Kettering Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR (time frame: 8 weeks post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2025.