Molecular Evaluation in Metastatic Breast Cancer

NCT03358589 | Unknown DMC

• 1 other identifier: MESTAR
• Study Type: interventional
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Breast Cancer; Molecular Imaging

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  Lesion based sensitivity analyses will be made for FDG-PET/CT and for diagnostic CT, and in patients with bone involvement also for WBMRI.

  2 years

Study Arms (1)

MESTAR

OTHER

All patients will have the same scans performed

Diagnostic Test: FDG-PET/CT

Interventions

FDG-PET/CT DIAGNOSTIC_TEST

Scans

Also known as: WBMRI

MESTAR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Due to breast cancer. Rare among men
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Men
• Pregnancy
• Severe Medical conditions
• severe mental og psychological conditions
• contraindications for MRI (for patients with bone metastasis)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Marianne Vogsen

Odense, Funen, DK-5000, Denmark

Location

Related Publications (3)

• Vogsen M, Naghavi-Behzad M, Harbo FG, Jakobsen NM, Gerke O, Asmussen JT, Nissen HJ, Dahlsgaard-Wallenius SE, Braad PE, Jensen JD, Ewertz M, Hildebrandt MG. 2-[18F]FDG-PET/CT is a better predictor of survival than conventional CT: a prospective study of response monitoring in metastatic breast cancer. Sci Rep. 2023 Apr 5;13(1):5552. doi: 10.1038/s41598-023-32727-w.

  PMID: 37019987 DERIVED

• Vogsen M, Jensen JD, Gerke O, Jylling AMB, Asmussen JT, Christensen IY, Braad PE, Thye-Ronn P, Soe KL, Ewertz M, Hildebrandt MG. Benefits and harms of implementing [18F]FDG-PET/CT for diagnosing recurrent breast cancer: a prospective clinical study. EJNMMI Res. 2021 Sep 22;11(1):93. doi: 10.1186/s13550-021-00833-3.

  PMID: 34553294 DERIVED

• Vogsen M, Geneser S, Rasmussen ML, Horder M, Hildebrandt MG. Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer. Res Involv Engagem. 2020 Jan 6;6:1. doi: 10.1186/s40900-019-0174-y. eCollection 2020.

  PMID: 31921443 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: it is a single-arm study
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: Prospective cohort

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 30, 2017
• Study Start: September 1, 2017
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2021
• Last Updated: May 25, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)