Clinical trial · Interventional
A Study of 1 8F-FDHT PET/MRIScans in Women With Breast Cancer
[18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging In Patients Advanced Breast Cancer
NCT06145399CI-TRIAL-00089900withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No accruals
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Female Breast Cancer | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Metastatic Breast Carcinoma | Breast Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT | Diagnostic Test | — | UNRESOLVED |
| 18F-FDHT | Drug | — | UNRESOLVED |
| [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Breast Cancer
- description
- Participants with histologically confirmed AR+ breast cancer
- interventionNames
- Diagnostic Test: 18F-FDG PET/CT
- Diagnostic Test: [18F]-Fluoro-2-Deoxy-D-Glucose and -[18F] Dihydro-Testosterone PET Imaging
- Drug: 18F-FDHT
Primary outcomes (1)
- measure
- Number of lesions that correlate 18F-FDHT uptake with IHC expression of AR
- timeFrame
- 8 weeks post treatment
- description
- The primary objective is to correlate 18F-FDHT uptake with IHC expression of AR as in selected lesions.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.