AR and ER Imaging in Metastatic Breast Cancer

This study has been completed.
Information provided by (Responsible Party):
G.A.P. Hospers, University Medical Center Groningen Identifier:
First received: November 1, 2013
Last updated: September 14, 2015
Last verified: September 2015
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 Intervention Phase
Metastatic Breast Cancer
Other: FDHT-PET scan
Other: FES-PET scan
Other: CT-scan
Other: Bone scintigraphy
Other: Tumor biopsy
Phase 2

Study Type: Interventional
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

Resource links provided by NLM:

Further study details as provided by University Medical Center Groningen:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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.

Enrollment: 24
Study Start Date: August 2014
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: FES/FDHT-PET Other: FDHT-PET scan Other: FES-PET scan Other: CT-scan Other: Bone scintigraphy Other: Tumor biopsy


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01988324

VU Medical Center
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Sponsors and Collaborators
G.A.P. Hospers
  More Information

No publications provided

Responsible Party: G.A.P. Hospers, MD PhD, University Medical Center Groningen Identifier: NCT01988324     History of Changes
Other Study ID Numbers: 2012.2708
Study First Received: November 1, 2013
Last Updated: September 14, 2015
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases processed this record on November 27, 2015