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OpenTrials
Completed

NCT Number: NCT02377934

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

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.

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Key information

Conditions

Pulmonary Hypertension Cardiovascular Diseases Hypertension Hypertension, Pulmonary Lung Diseases Respiratory Tract Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cardiac Magnetic Resonance Imaging (MRI)

Radiation

Primary outcomes

  1. Changes in pulmonary artery pressure

    Time frame: 6 and 12 weeks after completion chemoradiotherapy

Secondary outcomes

  1. Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function

    Time frame: 6 and 12 weeks after completion chemoradiotherapy

  2. The assessment of RV-dimensions and RV-function

    Time frame: 6 and 12 weeks after completion chemoradiotherapy

  3. The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria

    Time frame: 6 weeks after completion treatment

  4. The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0

    Time frame: 12 weeks after completion of treatment

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: MRI-HART

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Nov 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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