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AR and ER Imaging in Metastatic Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 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: August 19, 2014
Last verified: August 2014
  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:
  • 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.


Estimated Enrollment: 20
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)
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

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
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, see Learn About Clinical Studies.

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: 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
Groningen, Netherlands
Principal Investigator: G. A.P. Hospers, MD, PhD         
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: August 19, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

ClinicalTrials.gov processed this record on November 20, 2014