Automated Quantification of Coronary Artery Calcifications on Radiotherapy Planning CTs for Cardiovascular Risk Prediction in Breast Cancer Patients: the BRAGATSTON Study

February 5, 2024 updated by: Helena M Verkooijen, UMC Utrecht
The aim of the BRAGATSTON study is to provide a low cost tool for measuring CAC in breast cancer patients, thereby identifying patients at increased risk of CVD. Breast cancer patients and doctors can act upon this, by adapting the treatment and/or by adopting cardioprotective interventions. Hereby, the burden of CVD in breast cancer survivors can be reduced and better overall survival rates can be achieved.

Study Overview

Status

Completed

Conditions

Detailed Description

Cardiovascular disease (CVD) is the second most common cause of death in breast cancer patients. Certain adjuvant treatments (e.g. anthracyclines, radiotherapy) increase the risk of CVD, in particular in patients with pre-existing CVD risk factors. Early identification of these patients enables targeted cardioprotective interventions, and switching to less cardiotoxic treatments. The strongest independent CVD risk factor is the presence and amount of coronary artery calcium (CAC). In clinical practice, CAC is quantified on cardiac CTs. Breast cancer patients treated with radiotherapy routinely undergo planning CTs. These inferior quality CTs may give the opportunity to routinely assess CAC.

The BRAGATSTON study is a multicenter retrospective observational cohort study (UMC Utrecht, Erasmus Medical Center and Radboudumc). The project is divided into three work packages (WP), each WP with a unique aim:

WP 1: To develop/optimize and validate the UMC Utrecht developed automated software to determine the presence and the amount of CAC (CAC score) on radiotherapy planning CT scans of breast cancer patients.

WP 2a: To evaluate the association between CAC score measured automatically on planning CT scans and the risk of incident (non-)fatal cardiovascular events in breast cancer patients.

WP 2b: To evaluate if the association as defined by work package 2a is modified by type of adjuvant treatment.

WP 2c: To evaluate the association between other candidate imaging biomarkers (e.g. calcifications in other structures like the aorta or heart valves, the amount and distribution of body fat, bone characteristics) measured (automatically) on planning CT scans and the risk of incident (non-)fatal (cardiovascular) events in breast cancer patients.

WP 3: To assess the added value of CAC score measured automatically on planning CT scans over classic cardiovascular risk factors and over treatment characteristics to predict (non-)fatal cardiovascular events in breast cancer patients.

Study Type

Observational

Enrollment (Actual)

16000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Nijmegen, Netherlands
        • Radboudumc
      • Rotterdam, Netherlands
        • Erasmus Medical Center
      • Utrecht, Netherlands
        • University Medical Center Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Breast cancer patients treated with radiotherapy

Description

Inclusion Criteria:

  • Breast cancer patients treated with radiotherapy in UMC Utrecht, Erasmus Medical Center or Radboudumc between 2004-16
  • Planning CT scan available
  • Age: ≥18 years
  • Gender: both genders

Exclusion Criteria:

  • Not applicable

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Breast cancer patients treated with radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incident (non-)fatal (cardiovascular) diseases
Time Frame: Up to 13 years of follow-up, in hazard ratios
Up to 13 years of follow-up, in hazard ratios

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UMC Utrecht

Collaborators

Radboud University Medical Center
Erasmus Medical Center

Investigators

  • Principal Investigator: Helena M. Verkooijen, MD, PhD, Imaging Division, University Medical Center Utrecht, Utrecht
  • Principal Investigator: Ivana Išgum, PhD, Image Sciences Institute, University Medical Center Utrecht, Utrecht
  • Principal Investigator: Luca Incrocci, MD, PhD, Department of Radiation Oncology, Erasmus Medical Center, Rotterdam
  • Principal Investigator: Hanneke Meijer, MD, PhD, Department of Radiation Oncology, Radboudumc, Nijmegen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2017

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

March 1, 2020

Study Registration Dates

First Submitted

June 28, 2017

First Submitted That Met QC Criteria

June 30, 2017

First Posted (Actual)

July 2, 2017

Study Record Updates

Last Update Posted (Estimated)

February 6, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/721 (IRB UMC Utrecht)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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