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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02377934
Acronym
MRI-HART
Enrollment
9
Registered
2015-03-04
Start date
2012-09-30
Completion date
2015-08-31
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension, Cardiac MRT, Radiotherapy

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.

Interventions

Sponsors

University Medical Center Groningen
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Changes in pulmonary artery pressure6 and 12 weeks after completion chemoradiotherapy

Secondary

MeasureTime frame
Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function6 and 12 weeks after completion chemoradiotherapy
The assessment of RV-dimensions and RV-function6 and 12 weeks after completion chemoradiotherapy
The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria6 weeks after completion treatment
The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.012 weeks after completion of treatment

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026