AR and ER Imaging in Metastatic Breast Cancer
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.
Metastatic Breast Cancer
Other: FDHT-PET scan
Other: FES-PET scan
Other: Bone scintigraphy
Other: Tumor biopsy
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Androgen Receptor and Estrogen Receptor Imaging in Metastatic Breast Cancer Patients|
- Sensitivity/ specificity [ Time Frame: within two months ] [ Designated as safety issue: No ]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.
- Accuracy [ Time Frame: within six weeks ] [ Designated as safety issue: No ]The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.
- Inter- and intra-patient variation [ Time Frame: within six weeks ] [ Designated as safety issue: No ]Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.
- Inter-observer variation [ Time Frame: approximately two months ] [ Designated as safety issue: No ]Inter-observer variation in FES PET and FDHT PET results in two independent observers.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||January 2016|
|Estimated Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
|Experimental: FES/FDHT-PET||Other: FDHT-PET scan Other: FES-PET scan Other: CT-scan Other: Bone scintigraphy Other: Tumor biopsy|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988324
|Contact: Geke AP Hospers, MD PhD||+31 firstname.lastname@example.org|
|VU Medical Center||Not yet recruiting|
|Contact: C. W. Menke-v.d. Houven van Oordt, MD PhD|
|Principal Investigator: C. W. Menke-v.d. Houven van Oordt, MD, PhD|
|University Medical Center Groningen||Recruiting|
|Principal Investigator: G. A.P. Hospers, MD, PhD|