Grant received in 2022

DCCC has funded 150,000 DKK to the project

Evidence from a recent retrospective study indicated that FDG-PET/CT has the potential to guide treatment decisions and improve patient survival with an average of 14 months longer survival time for patients monitored with FDG-PET/CT compared with conventional CT. This potential benefit needs confirmation in a randomized trial. Therefore, we propose to perform a prospective multicenter randomized controlled trial, comparing response evaluation with FDG-PET/CT vs. conventional CT. Corresponding response evaluation criteria, RECIST, (conventional) or FDG-PET/CT with the response evaluation criteria, PERCIST, (intervention) will be applied.

The primary endpoint is overall survival, while quality-of-life and cost are secondary endpoints. Preparing meetings will include training and consensus on clinical decision-making when applying FDG-PET/CT and the PERCIST response evaluation criteria.

Six Danish centers will participate in the study hosted at Odense University Hospital.

Multidisciplinary organisation
DBCG -  Danish Breast Cancer Cooperative Group

Project stakeholder

The collaboration includes experts in oncology, nuclear medicine, radiology, physics, health economics, and statistics. Odense University Hospital is the hosting institution with the main applicant as the principal investigator who has vast experience in FDG-PET/CT and PERCIST analyses in MBC. Local collaborators are Marianne Vogsen (MVO), MD, PhD and Mohammad Naghavi- Behzad (MNB) MD, MPH, PhD student (third year) who will be postdocs on the project, collaborating with a PhD student (NN).

Professor in breast oncology, Marianne Ewertz, and professor and head of research from the Department of Radiology, Ole Graumann participate with their relevant expertise. Professor, health economist Kristian Kidholm will contribute to cost analyses.

Statistical plans and analyses will be supervised by professors in biostatistics. With expertise in diagnostic study designs, professor Werner Vach from Basel Academy for Quality and Research in Medicine and professor Oke Gerke from the hosting institution participate in the project team. With expertise in survival analyses, ass. professor Theis Lange who is leader of the Department of Public Health, University of Copenhagen participates as a team consultant in the study.

Primary contact: Malene Grubbe Hildebrandt, Consultant, Associate professor, Head of research, Odense University Hospital. E-mail: malene.grubbe.hildebrandt@rsyd.dk

The following six clinical centers representing four Danish regions have consented to participate:

Rigshospitalet

  • Consultant Ann S. Knop, MD, PhD, Department of Oncology, and Chairman of the Medical Committee of the Danish Breast Cancer Cooperative Group, and professor, consultant in nuclear medicine Malene Fischer, MD, DMSc.

Aarhus University Hospital

  • Chair professor and senior consultant Signe Borgquist, MD, PhD, Department of Oncology, and ass. professor in nuclear medicine Mikkel Vendelbo, MD, PhD.

Herlev Hospital

  • Ass. professor, consultant Iben Kümler, MD, PhD, Department of Oncology and senior consultant in nuclear medicine Charlotte Birk Christensen, MD.

Aalborg University Hospital

  • Consultant Tamás Lorincz, MD, Department of Oncology, and ass. professor, consultant Helle Zacho, MD, Department of Nuclear Medicine.

Hospital Lillebaelt

  • Consultant Else Maae, MD, PhD, Department of Oncology and ass. professor in nuclear medicine Paw Holdgaard, and radiologist Lone Lange Østergård.

Hospital of South West Jutland

  • Ass. professor, consultant, Søren Hess, chair of the Danish Society of Clinical Physiology and Nuclear Medicine participates.