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

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ClinicalTrials.gov Identifier: NCT02377934
Recruitment Status : Completed
First Posted : March 4, 2015
Last Update Posted : September 15, 2015
Sponsor:
Information provided by (Responsible Party):
Joachim Widder, MD PhD, University Medical Center Groningen

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.


Condition or disease Intervention/treatment
Pulmonary Hypertension Radiation: Cardiac Magnetic Resonance Imaging (MRI)

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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
Study Start Date : September 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Changes in pulmonary artery pressure [ Time Frame: 6 and 12 weeks after completion chemoradiotherapy ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with stage III NSCLC
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377934


Locations
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Netherlands
University Medical Center Groningen
Groningen, Netherlands, 9700RB
Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Joachim Widder, MD PhD University Medical Center Groningen
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Responsible Party: Joachim Widder, MD PhD, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02377934    
Other Study ID Numbers: RT2011-02
First Posted: March 4, 2015    Key Record Dates
Last Update Posted: September 15, 2015
Last Verified: September 2015
Keywords provided by Joachim Widder, MD PhD, University Medical Center Groningen:
Pulmonary Hypertension
Cardiac MRT
Radiotherapy
Additional relevant MeSH terms:
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Hypertension, Pulmonary
Hypertension
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases