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

NCT02377934 | Completed

• 1 other identifier: RT2011-02
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Hypertension

Keywords

Pulmonary Hypertension; Cardiac MRT; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Changes in pulmonary artery pressure

  6 and 12 weeks after completion chemoradiotherapy

Secondary Outcomes (4)

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

  6 and 12 weeks after completion chemoradiotherapy

• The assessment of RV-dimensions and RV-function

  6 and 12 weeks after completion chemoradiotherapy

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

  6 weeks after completion treatment

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

  12 weeks after completion of treatment

Interventions

Cardiac Magnetic Resonance Imaging (MRI) RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with stage III NSCLC

You may qualify if:

• 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.

You may not qualify if:

• Presence of contra-indications for undergoing MRI

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Hypertension, Pulmonary

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Robin Wijsman

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 4, 2015
• Study Start: September 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: November 4, 2022

Record last verified: 2022-11

Locations

NL (1)