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

NCT ID: NCT02377934

Last Updated: 2022-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

9 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Hypertension

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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Cardiac Magnetic Resonance Imaging (MRI)

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Medical Center Groningen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robin Wijsman

Role: PRINCIPAL_INVESTIGATOR

UMCG

Locations

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University Medical Center Groningen

Groningen, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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RT2011-02

Identifier Type: -

Identifier Source: org_study_id

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