We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT03358589
Previous Study | Return to List | Next Study

Molecular Evaluation in Metastatic Breast Cancer (MESTAR)

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.
ClinicalTrials.gov Identifier: NCT03358589
Recruitment Status : Active, not recruiting
First Posted : November 30, 2017
Last Update Posted : May 25, 2021
Information provided by (Responsible Party):
Marianne Vogsen, Odense University Hospital

Brief Summary:

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 or disease Intervention/treatment Phase
Metastatic Breast Cancer Molecular Imaging Diagnostic Test: FDG-PET/CT Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 270 participants
Allocation: N/A
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
Actual Study Start Date : September 1, 2017
Actual Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
All patients will have the same scans performed
Diagnostic Test: FDG-PET/CT
Other Name: WBMRI

Primary Outcome Measures :
  1. 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.

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.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Due to breast cancer. Rare among men
Accepts Healthy Volunteers:   Yes

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))

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

Layout table for location information
Marianne Vogsen
Odense, Funen, Denmark, DK-5000
Sponsors and Collaborators
Odense University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Marianne Vogsen, MD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT03358589    
Other Study ID Numbers: MESTAR
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: May 25, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases