Recruiting

Observational Study

Sponsor:

University Health Network, Toronto

Code:

NCT04901884

Conditions

Pulmonary Hypertension

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PET/MR with 18F-FDG

Study Details

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.

Conditions

Pulmonary Hypertension

Study ID

NCT04901884

Start date

Jun 1, 2021

Status verified date

Dec, 2025

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Jun 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: One arm / exploratory study

Injection of 18F-FDG.The 18F-FDG cardiac PET-MR scanning visit will take up to 1.5 hours.

Interventions

PET/MR with 18F-FDG

(18F) Fluorodeoxyglucose (FDG) will be administered by intravenous injection at a dose of 4-5 MBq/kg.

Primary outcome measure

  • Change of FDG uptake of heart [ Time Frame: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy ]
  • Change of FDG uptake of lungs [ Time Frame: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy ]
  • Change of the heart function [ Time Frame: at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy ]
  • Change of the lung perfusion [ Time Frame: before radiotherapy and up to 16 weeks after completion of radiotherapy ]

Central Contacts and Locations

Central contacts

Patrick Veit-Haibach, MD

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

Andrew Hope, MD

416-946-2124Andrew.Hope@rmp.uhn.ca

Locations

University Health Network

Recruiting

Toronto, Ontario, Canada, M5G 2M9

More Information

Sponsor

University Health Network, Toronto

Last update posted

Dec 10, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2025-12-10.