We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

AR and ER Imaging in Metastatic Breast Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01988324
First Posted: November 20, 2013
Last Update Posted: September 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
G.A.P. Hospers, University Medical Center Groningen
  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: None (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 G.A.P. Hospers, University Medical Center Groningen:

Primary Outcome Measures:
  • Sensitivity/ specificity [ Time Frame: within two months ]
    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 ]
    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 ]
    Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.

  • Inter-observer variation [ Time Frame: approximately two months ]
    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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01988324


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

Responsible Party: G.A.P. Hospers, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT01988324     History of Changes
Other Study ID Numbers: 2012.2708
First Submitted: November 1, 2013
First Posted: November 20, 2013
Last Update Posted: September 15, 2015
Last Verified: September 2015

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