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

NCT04901884 | Recruiting

• 1 other identifier: 18-5879
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (4)

• Change of FDG uptake of heart

  FDG uptake of the left and right ventricles of heart will be measured and compared in PETMRI scans

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

• Change of FDG uptake of lungs

  FDG uptake of left and right ratios within the lungs in PETMRI scans

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

• Change of the heart function

  MRI of ventricular volumes in PETMRI scans

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

• Change of the lung perfusion

  Percentage of the perfused/ventilated lung segments will be evaluated and compared pre and post therapy by SPECT scans

  before radiotherapy and up to 16 weeks after completion of radiotherapy

Study Arms (1)

One arm / exploratory study

EXPERIMENTAL

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

Drug: PET/MR with 18F-FDG

Interventions

PET/MR with 18F-FDG DRUG

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

One arm / exploratory study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Hypertension, Pulmonary

Interventions

Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Study Officials

• Patrick Veit-Haibach, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Veit-Haibach, MD

CONTACT

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

Andrew Hope, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Biopsy or otherwise clinically proven thoracic malignant mass which is intended to be treated with radio(chemo)therapy

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: May 26, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (1)