AR and ER Imaging in Metastatic Breast Cancer

This study is not yet open for participant recruitment.
Verified November 2013 by University Medical Centre Groningen
Sponsor:
Information provided by (Responsible Party):
G.A.P. Hospers, University Medical Centre Groningen
ClinicalTrials.gov Identifier:
NCT01988324
First received: November 1, 2013
Last updated: November 19, 2013
Last verified: November 2013
  Purpose

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 Centre Groningen:

Primary Outcome Measures:
  • Concordance between PET results and immunohistochemistry on biopsied lesions [ Time Frame: within two months ] [ Designated as safety issue: No ]
    To evaluate the concordance between PET (with 18F-FDHT and 18F-FES), and immunohistochemistry (for AR and ER) on concurrent (within 8 weeks) tumor biopsy.


Secondary Outcome Measures:
  • The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy. [ Time Frame: within six weeks ] [ Designated as safety issue: No ]
  • Inter- and intra-patient variation in tracer uptake. [ Time Frame: within six weeks ] [ Designated as safety issue: No ]
  • Inter-observer variation in FES PET and FDHT PET results in two independent observers. [ Time Frame: approximately two months ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: December 2013
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single arm Other: FDHT-PET scan Other: FES-PET scan Other: CT-scan Other: Bone scintigraphy Other: Tumor biopsy

  Eligibility

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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01988324

Contacts
Contact: Geke AP Hospers, MD PhD +31 503612775 g.a.p.hospers@umcg.nl

Locations
Netherlands
VU Medical Center Not yet recruiting
Amsterdam, Netherlands
Contact: Epi Boven, MD PhD         
University Medical Center Groningen Not yet recruiting
Groningen, Netherlands
Sponsors and Collaborators
G.A.P. Hospers
  More Information

No publications provided

Responsible Party: G.A.P. Hospers, MD PhD, University Medical Centre Groningen
ClinicalTrials.gov Identifier: NCT01988324     History of Changes
Other Study ID Numbers: 2012.2708
Study First Received: November 1, 2013
Last Updated: November 19, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 20, 2014