RecruitingNot Applicable

PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation

Canada40 participantsStarted 2021-06-01

Plain-language summary

Radiotherapy (RT) is a well-known and established therapy or adjuvant therapy for the treatment of thoracic cancer It uses a high energy radiation from x-rays, gamma rays and other charged particles that assist in damaging the cancer DNA. PET/MR as imaging biomarkers for cardiopulmonary dysfunction with a focus on Pulmonary hypertension (PH). Despite the measures taken to reduce the total radiation dose and to limit the radiation to normal tissues, there is evidence of transient or permanent radiotherapy induced myocardial and pulmonary dysfunction leading to PH in patients who receive radiotherapy above a certain threshold of received dose. To be able to Demonstrate correlation of combined PET/MR and plasma metabolomics markers in patients at risk of developing cardiopulmonary disfunction after RT.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age ≥18 years * Biopsy or otherwise clinically proven thoracic malignant mass which is intended to be treated with radio(chemo)therapy * Intention to treat with radio(chemo)therapy with incidental cardiac irradiation of at least 25Gy. * A negative urine or serum pregnancy test within the two week interval immediately prior to imaging, in women of child-bearing age. * Ability to provide written informed consent to participate in the study (for all components of the trial: imaging with cardiac PET/MR, blood sampling for plasma metabolomics and circulating DNA). Exclusion Criteria: * Contraindication for MR as per current institutional guidelines. * Contraindication for Gadolinium injection as per current institutional guidelines. * Inability to lie supine for at least 45 minutes. * Any patient who is pregnant or breastfeeding. * Any patient with known hypersensitivity to 18F-FDG.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change of FDG uptake of heart

Timeframe: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy

Change of FDG uptake of lungs

Timeframe: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy

Change of the heart function

Timeframe: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy

Change of the lung perfusion

Timeframe: before radiotherapy and up to 16 weeks after completion of radiotherapy

Trial details

NCT IDNCT04901884

SponsorUniversity Health Network, Toronto

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-06-01

Contact for this trial

Patrick Veit-Haibach, MD

416-340-4800 Patrick.Veit-Haibach@uhn.ca

View on ClinicalTrials.gov More Pulmonary Hypertension trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change of FDG uptake of heart

Timeframe: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy

Change of FDG uptake of lungs

Timeframe: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy

Change of the heart function

Timeframe: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy

Change of the lung perfusion

Timeframe: before radiotherapy and up to 16 weeks after completion of radiotherapy