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Molecular Evaluation in Metastatic Breast Cancer

NCT03358589 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2021-05-25

No results posted yet for this study

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

Interventions

DIAGNOSTIC_TEST

FDG-PET/CT

Scans

Sponsors & Collaborators

  • Odense University Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-08-31
Completion
2021-08-31

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03358589 on ClinicalTrials.gov