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NCT03358589: MESTAR

Molecular Evaluation in Metastatic Breast Cancer

Status unknown NA Last updated 25 May 2021
What this trial tests

NA trial testing FDG-PET/CT in Metastatic Breast Cancer in 270 participants. Status unknown.

Timeline
1 September 2017
Primary endpoint
31 August 2019
31 August 2021

Quick facts

Lead sponsorOdense University Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment270
Start date1 September 2017
Primary completion31 August 2019
Estimated completion31 August 2021
Sites1 location across Denmark

Drugs / interventions tested

Conditions studied

Sponsor

Odense University Hospital

Who can join

18 and older, female only, with Metastatic Breast Cancer or Molecular Imaging. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Response Monitoring in Metastatic Breast Cancer: A Prospective Study Comparing <sup>18</sup>F-FDG PET/CT with Conventional CT.
    Vogsen M, Harbo F, Jakobsen NM, Nissen HJ, et al · · 2023 · cited 22× · PMID 36207136 · DOI 10.2967/jnumed.121.263358
  2. Benefits and harms of implementing [<sup>18</sup>F]FDG-PET/CT for diagnosing recurrent breast cancer: a prospective clinical study.
    Vogsen M, Jensen JD, Gerke O, Jylling AMB, et al · · 2021 · cited 21× · PMID 34553294 · DOI 10.1186/s13550-021-00833-3
  3. 2-[<sup>18</sup>F]FDG-PET/CT is a better predictor of survival than conventional CT: a prospective study of response monitoring in metastatic breast cancer.
    Vogsen M, Naghavi-Behzad M, Harbo FG, Jakobsen NM, et al · · 2023 · cited 13× · PMID 37019987 · DOI 10.1038/s41598-023-32727-w
  4. Learning from patient involvement in a clinical study analyzing PET/CT in women with advanced breast cancer.
    Vogsen M, Geneser S, Rasmussen ML, Hørder M, et al · · 2020 · cited 11× · PMID 31921443 · DOI 10.1186/s40900-019-0174-y
  5. Comparison of Image Quality and Quantification Parameters between Q.Clear and OSEM Reconstruction Methods on FDG-PET/CT Images in Patients with Metastatic Breast Cancer.
    Naghavi-Behzad M, Vogsen M, Gerke O, Dahlsgaard-Wallenius SE, et al · · 2023 · cited 5× · PMID 36976116 · DOI 10.3390/jimaging9030065
  6. European Association of Nuclear Medicine October 20-23, 2021 Virtual.
    · 2021 · cited 5× · PMID 34559267 · DOI 10.1007/s00259-021-05547-1
  7. The Pattern of Metastatic Breast Cancer: A Prospective Head-to-Head Comparison of [<sup>18</sup>F]FDG-PET/CT and CE-CT.
    Gram-Nielsen R, Christensen IY, Naghavi-Behzad M, Dahlsgaard-Wallenius SE, et al · · 2023 · cited 2× · PMID 37888329 · DOI 10.3390/jimaging9100222
  8. Benefits And Harms Of Implementing [18F]FDG-PET/CT For Diagnosing Recurrent Breast Cancer: A Prospective Clinical Study
    Vogsen M, Jensen JD, Gerke O, Jylling AMB, et al · · 2021 · DOI 10.21203/rs.3.rs-571795/v1

Verify or expand the search:

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Other Odense University Hospital trials

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