Clinical trial NCT02377934: Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Official title: Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Hypertension
Keywords: Pulmonary Hypertension
Cardiac MRT
Radiotherapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-03-04
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with stage III NSCLC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in pulmonary artery pressure
timeFrame: 6 and 12 weeks after completion chemoradiotherapy
Secondary outcomes:
measure: Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function
timeFrame: 6 and 12 weeks after completion chemoradiotherapy
measure: The assessment of RV-dimensions and RV-function
timeFrame: 6 and 12 weeks after completion chemoradiotherapy
measure: The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria
timeFrame: 6 weeks after completion treatment
measure: The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0
timeFrame: 12 weeks after completion of treatment
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: UMCG
name: Robin Wijsman
role: PRINCIPAL_INVESTIGATOR
References: