PET/MR with 18F-FDG: (18F) Fluorodeoxyglucose (FDG) will be administered by intravenous injection at a dose of 4-5 MBq/kg.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change of FDG uptake of heart — at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy FDG uptake of the left and right ventricles of heart will be measured and compared in PETMRI scans
Change of FDG uptake of lungs — at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy FDG uptake of left and right ratios within the lungs in PETMRI scans
Change of the heart function — at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy MRI of ventricular volumes in PETMRI scans
Change of the lung perfusion — before radiotherapy and up to 16 weeks after completion of radiotherapy Percentage of the perfused/ventilated lung segments will be evaluated and compared pre and post therapy by SPECT scans
Trial sites (1)
Facility
City
Region
Status
University Health Network
Toronto
Ontario
Recruiting
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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