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ClinicalTrials.gov Identifier: NCT01988324
Recruitment Status :
First Posted : November 20, 2013
Last Update Posted : September 15, 2015
Information provided by (Responsible Party):
G.A.P. Hospers, University Medical Center Groningen
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.
Condition or disease
Metastatic Breast Cancer
Other: FDHT-PET scanOther: FES-PET scanOther: CT-scanOther: Bone scintigraphyOther: Tumor biopsy
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Metastatic breast cancer, with at least one known metastasis outside of the liver
Presence of a lesion that is safely accessible for tumor biopsy (may be liver lesion)
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
Initially ER-positive tumor histology.
ECOG performance status 0-2.
Signed written informed consent
Able to comply with the protocol
Use of estrogen receptor ligands, including tamoxifen, fulvestrant or estrogens, or androgen receptor ligands, during the 6 weeks before entry into the study