Recruiting

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

ClinicalTrials.gov IDNCT04901884

PhaseNA

Enrollment40

SponsorUniversity Health Network, Toronto

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Pulmonary Hypertension

About this study

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.

Interventions

Drug: PET/MR with 18F-FDG — (18F) Fluorodeoxyglucose (FDG) will be administered by intravenous injection at a dose of 4-5 MBq/kg.

Primary outcomes

Change of FDG uptake of heart (at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy)
Change of FDG uptake of lungs (at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy)
Change of the heart function (at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy)
Change of the lung perfusion (before radiotherapy and up to 16 weeks after completion of radiotherapy)

Eligibility information

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.

Study locations

University Health Network, Toronto, Ontario M5G 2M9 Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.