Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study (MRI-HART)

November 3, 2022 updated by: University Medical Center Groningen

In the radiotherapeutic treatment of lung cancer, the dose that can be safely applied to the tumour is limited by the risk of radiation induced lung damage. This damage is characterized by parenchymal damage and vascular damage. In rats, we have found that radiation-induced vascular damage results in increased pulmonary artery pressure. Interestingly, the consequent loss of pulmonary function could be fully explained by this increase in pulmonary artery pressure. We hypothesize that also in patients a radiation induced increase in pulmonary artery pressure can be observed after radiotherapy, which may contribute to the development of radiation pneumonitis.

The objective is to test the hypothesis that radiotherapy for lung cancer induces an increase in pulmonary artery pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

9

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
      • Groningen, Netherlands, 9700RB
        • University Medical Center Groningen

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with stage III NSCLC

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • WHO PS 0-2
  • Histological or cytological confirmation of non-small cell lung cancer or an 18F-FDG-positive, growing mass on CT-thorax suggestive of NSCLC.
  • Stage IIIA or IIIB
  • Patients with extensive mediastinal lymph node involvement (such as N3), or large primary tumour size
  • Adequate pulmonary function estimated by flow volume curves
  • Life expectancy of at least 6 months
  • Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol; those conditions should be discussed with the patient before registration in the trial.
  • Planned for 25 x 2.4 Gy, with concomitant chemotherapy
  • Before patient registration, written informed consent will be obtained.

Exclusion Criteria:

  • Presence of contra-indications for undergoing MRI

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in pulmonary artery pressure
Time Frame: 6 and 12 weeks after completion chemoradiotherapy
6 and 12 weeks after completion chemoradiotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function
Time Frame: 6 and 12 weeks after completion chemoradiotherapy
6 and 12 weeks after completion chemoradiotherapy
The assessment of RV-dimensions and RV-function
Time Frame: 6 and 12 weeks after completion chemoradiotherapy
6 and 12 weeks after completion chemoradiotherapy
The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria
Time Frame: 6 weeks after completion treatment
6 weeks after completion treatment
The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0
Time Frame: 12 weeks after completion of treatment
12 weeks after completion of treatment

Collaborators and Investigators

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

Sponsor

University Medical Center Groningen

Investigators

  • Principal Investigator: Robin Wijsman, UMCG

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

September 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

February 27, 2015

First Submitted That Met QC Criteria

February 27, 2015

First Posted (Estimate)

March 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 3, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RT2011-02

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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