NCT04901884 PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation
| NCT ID | NCT04901884 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Health Network, Toronto |
| Condition | Pulmonary Hypertension |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2021-06-01 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Patrick Veit-Haibach, MD
PRINCIPAL INVESTIGATOR
University Health Network, Toronto
Frequently Asked Questions
Who can join the NCT04901884 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Pulmonary Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04901884 currently recruiting?
Yes, NCT04901884 is actively recruiting participants. Contact the research team at Patrick.Veit-Haibach@uhn.ca for enrollment information.
Where is the NCT04901884 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04901884 clinical trial?
NCT04901884 is sponsored by University Health Network, Toronto. The principal investigator is Patrick Veit-Haibach, MD at University Health Network, Toronto. The trial plans to enroll 40 participants.