Molecular Evaluation in Metastatic Breast Cancer (MESTAR)
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|ClinicalTrials.gov Identifier: NCT03358589|
Recruitment Status : Active, not recruiting
First Posted : November 30, 2017
Last Update Posted : May 25, 2021
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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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective cohort|
|Masking:||None (Open Label)|
|Masking Description:||it is a single-arm study|
|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|
All patients will have the same scans performed
Diagnostic Test: FDG-PET/CT
Other Name: WBMRI
- 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.
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|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|
- 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
- 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))
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
|Odense, Funen, Denmark, DK-5000|
|Responsible Party:||Marianne Vogsen, MD, Odense University Hospital|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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