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

Molecular Evaluation in Metastatic Breast Cancer (MESTAR)

This study is currently recruiting participants.
Verified November 2017 by Marianne Vogsen, Odense University Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT03358589
First Posted: November 30, 2017
Last Update Posted: December 1, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Marianne Vogsen, Odense University Hospital
  Purpose

Background: Despite that up 90% of patients with early-stage breast cancer receives adjuvant treatment, there are still about 300 patients diagnosed with primary metastatic breast cancer (MBC) and about 1,200 patients who develop metastases after the primary treatment each year in Denmark.

Aim: The investigators hypothesize that molecular evaluation with FDG-PET/CT and diffusion weighted MRI allows an earlier detection of failure to respond to potentially toxic drugs in patients receiving breast cancer directed treatments.

The aims of our project are to address the following questions:

  • Does FDG-PET/CT allow an earlier detection of failure to respond to treatment for MBC than conventional CT?
  • Does FDG-PET/CT or MRI allow an earlier detection of failure to respond to treatment for bone metastatic disease than conventional CT?
  • Does the PET based criteria (PERCIST) have the potential to lead to changes in the treatment plans made from CT based criteria (RECIST)?
  • Does FDG-PET/CT give a more accurate diagnosis of MBC than conventional CT in terms of number and distribution of metastatic sites?

Method: Part A - the accuracy study: The study population will comprise all women referred to Odense University Hospital with suspected metastatic breast cancer (MBC). The investigators expect to include 270 patients who will be examined with FDG-PET/CT. If bone metastases are detected, the patients will proceed to MRI. All patients with suspected metastases on FDG-PET/CT or MRI will have a biopsy from a suitable lesion Part B - the response evaluation study: The investigators expect to include 90 patients with biopsy-verified MBC. Patients will receive oncologic treatment according to national guidelines. Response to treatment will be evaluated by conventional CT criteria and compared to novel criteria according to FDG- PET/CT, and MRI. Test results will be blinded to each other, so that knowledge of other test results will be unknown for the reader of the CT, FDG-PET/CT or MRI, respectively Expected clinical impact: This project represents a truly multidisciplinary effort to improve the diagnosis, staging, and response evaluation of MBC. The investigators hope that patients will benefit in terms of being spared for ineffective toxic treatment due to earlier detection of failure to respond, and hence leading to earlier treatment transition. Patients are involved in the planning and conduct of the project.


Condition Intervention
Metastatic Breast Cancer Molecular Imaging Diagnostic Test: FDG-PET/CT

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Intervention Model Description:
Prospective cohort
Masking: None (Open Label)
Masking Description:
it is a single-arm study
Primary Purpose: Diagnostic
Official Title: Molecular Evaluation in Metastatic Breast Cancer - A Clinical Study of Accuracy and Response Assessment

Resource links provided by NLM:


Further study details as provided by Marianne Vogsen, Odense University Hospital:

Primary Outcome Measures:
  • Sensitivity [ Time Frame: 2 years ]
    Lesion based sensitivity analyses will be made for FDG-PET/CT and for diagnostic CT, and in patients with bone involvement also for WBMRI.


Estimated Enrollment: 270
Actual Study Start Date: September 1, 2017
Estimated Study Completion Date: August 31, 2021
Estimated Primary Completion Date: August 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MESTAR
All patients will have the same scans performed
Diagnostic Test: FDG-PET/CT
Scans
Other Name: WBMRI

  Show Detailed Description

  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:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Due to breast cancer. Rare among men
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women
  • Age > 18
  • Suspicion of recurrence of earlier breast cancer or new breast cancer diagnose with high risk of metastatic disease
  • Life expectancy > 3 month
  • Signed statement of consent

Exclusion Criteria:

  • Men
  • Pregnancy
  • Severe Medical conditions
  • severe mental og psychological conditions
  • contraindications for MRI (for patients with bone metastasis)
  • treatment for other malignant diseases within the last 5 years prior to inclusion (except carcinoma in situ cervicis uteri and basal cell carcinoma (BCC))
  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): NCT03358589


Locations
Denmark
Marianne Vogsen Recruiting
Odense, Funen, Denmark, DK-5000
Contact: Marianne Vogsen, MD    0045 50932282    marianne.vogsen@rsyd.dk   
Contact: Malene Grubbe Hildebrandt, MD, PhD    0045 30171888    malene.grubbe.hildebrandt@rsyd.dk   
Sub-Investigator: Marianne Ewertz, Professor         
Sub-Investigator: Jeanette Dupont Jensen, MD, PhD         
Sub-Investigator: Malene Grubbe Hildebrandt, MD, PhD         
Principal Investigator: Marianne Vogsen, MD         
Sponsors and Collaborators
Odense University Hospital
  More Information

Responsible Party: Marianne Vogsen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03358589     History of Changes
Other Study ID Numbers: MESTAR
First Submitted: November 9, 2017
First Posted: November 30, 2017
Last Update Posted: December 1, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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