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Trial record 58 of 106 for:    "Kennedy disease"

AR and ER Imaging in Metastatic Breast Cancer

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. Identifier: NCT01988324
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : September 15, 2015
Information provided by (Responsible Party):
G.A.P. Hospers, University Medical Center Groningen

Brief Summary:
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 Intervention/treatment Phase
Metastatic Breast Cancer Other: FDHT-PET scan Other: FES-PET scan Other: CT-scan Other: Bone scintigraphy Other: Tumor biopsy Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
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
Study Start Date : August 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: FES/FDHT-PET Other: FDHT-PET scan
Other: FES-PET scan
Other: CT-scan
Other: Bone scintigraphy
Other: Tumor biopsy

Primary Outcome Measures :
  1. 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 :
  1. Accuracy [ Time Frame: within six weeks ]
    The number of lesions detected on PET imaging compared to CT-scan and bone scintigraphy.

  2. Inter- and intra-patient variation [ Time Frame: within six weeks ]
    Inter- and intra-patient variation in tumor FDHT and FES-uptake will be calculated.

  3. Inter-observer variation [ Time Frame: approximately two months ]
    Inter-observer variation in FES PET and FDHT PET results in two independent observers.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

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 identifier (NCT number): NCT01988324

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

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Responsible Party: G.A.P. Hospers, MD PhD, University Medical Center Groningen Identifier: NCT01988324     History of Changes
Other Study ID Numbers: 2012.2708
First Posted: November 20, 2013    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases