Pulmonary HypertensionMRI-HARTNCT02377934
Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
An observational study of Pulmonary Hypertension, run by University Medical Center Groningen at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Cardiac Magnetic Resonance Imaging (MRI)
- Type of treatment
- Surgery or procedure
- How many people
- 9 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2012to Aug 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with stage III NSCLC
Who may be able to join
- 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
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- 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.
Who cannot join
- Presence of contra-indications for undergoing MRI
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Cardiac Magnetic Resonance Imaging (MRI)
- Keywords
- Pulmonary Hypertension, Cardiac MRT, Radiotherapy
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance Imaging (MRI)Radiation
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in pulmonary artery pressure
Measured: 6 and 12 weeks after completion chemoradiotherapy
Secondary outcomes (4)
Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function
Measured: 6 and 12 weeks after completion chemoradiotherapy
The assessment of RV-dimensions and RV-function
Measured: 6 and 12 weeks after completion chemoradiotherapy
The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria
Measured: 6 weeks after completion treatment
The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0
Measured: 12 weeks after completion of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study startSep 2012
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin Wijsman, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377934
- Sponsor's protocol ID
- RT2011-02
- Acronym
- MRI-HART
- Status last verified
- Nov 2022
- First submitted
- 27 Feb 2015
- Last updated
- 4 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Radiation Induced Pulmonary Hypertension Using MRI in Stage III NSCLC Patients Treated With Chemoradiotherapy. A Pilot Study
- ClinicalTrials.gov ID
- NCT02377934
- Acronym / sponsor ID
- MRI-HART / RT2011-02
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary Hypertension, Cardiac MRT, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 4 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with stage III NSCLC
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (1 listed)
- Presence of contra-indications for undergoing MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance Imaging (MRI) | Radiation | – |
Primary outcome
Changes in pulmonary artery pressure
Time frame: 6 and 12 weeks after completion chemoradiotherapy
4 secondary outcomes
Pulmonary artery velocity; right ventricle (RV) dimensions and RV-function
Time frame: 6 and 12 weeks after completion chemoradiotherapy
The assessment of RV-dimensions and RV-function
Time frame: 6 and 12 weeks after completion chemoradiotherapy
The incidence of clinical signs of radiation pneumonitis according to SWOG-criteria
Time frame: 6 weeks after completion treatment
The incidence of radiological signs of pulmonary fibrosis according to CTCAE4.0
Time frame: 12 weeks after completion of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Wijsman principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Hypertension, run by University Medical Center Groningen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in pulmonary artery pressure (time frame: 6 and 12 weeks after completion chemoradiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.