Clinical trial · Interventional
AR and ER Imaging in Metastatic Breast Cancer
Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Knowledge of breast cancer estrogen receptor (ER) expression is of major importance in treatment-decision making. Patients with ER-positive tumors can be treated with anti-oestrogen therapy, which has relatively few side effects compared to chemotherapy. Whole-body tumor ER-expression can be visualized by 18F-fluoroestradiol PET imaging (FES-PET). In addition to ER, the androgen receptor (AR) is a potential new target in breast cancer. PET imaging with 18F-fluorodihydrotestosterone (18F-FDHT) may allow visualization of tumor AR-expression. In the current study we will perform FES-PET and FDHT-PET in metastatic breast cancer patients and evaluate the concordance with concurrent biopsies. Molecular imaging of tumor AR- and ER-expression may well be of value for future treatment decision-making.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bone scintigraphy | Other | — | UNRESOLVED |
| CT-scan | Other | — | UNRESOLVED |
| FDHT-PET scan | Other | — | UNRESOLVED |
| FES-PET scan | Other | — | UNRESOLVED |
| Tumor biopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- FES/FDHT-PET
- interventionNames
- Other: FDHT-PET scan
- Other: FES-PET scan
- Other: CT-scan
- Other: Bone scintigraphy
- Other: Tumor biopsy
Primary outcomes (1)
- measure
- Sensitivity/ specificity
- timeFrame
- within two months
- description
- The concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy will be evaluated.
Secondary outcomes (3)
- measure
- Accuracy
- timeFrame
- within six weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Metastatic breast cancer, with at least one known metastasis outside of the liver 2. Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion) 3. Postmenopausal status defined as one of the following: * age ≥60 years * previous bilateral oophorectomy * age \<60 years and amenorrhea for \>12 months in the absence of interfering hormonal therapies (such as LH-RH agonists and ER-antagonists) * patients age \<60 years using an ER-antagonist should have amenorrhea for \> 12 months and FSH \>24 U/L and LH \>14 U/L e. patient age \<60 years using LH-RH agonists should continue LH-RH-agonists until after the PET procedures 4. Initially ER-positive tumor histology. 5. ECOG performance status 0-2. 6. Signed written informed consent 7. Able to comply with the protocol Exclusion Criteria: 1. Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study 2. Life-expectancy ≤ 3 months
References
Publications (1)
- DERIVEDMammatas LH, Venema CM, Schroder CP, de Vet HCW, van Kruchten M, Glaudemans AWJM, Yaqub MM, Verheul HMW, Boven E, van der Vegt B, de Vries EFJ, de Vries EGE, Hoekstra OS, Hospers GAP, der Houven van Oordt CWM. Visual and quantitative evaluation of [18F]FES and [18F]FDHT PET in patients with metastatic breast cancer: an interobserver variability study. EJNMMI Res. 2020 Apr 19;10(1):40. doi: 10.1186/s13550-020-00627-z. PMID 32307594