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

ConditionPulmonary Hypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Health Network, Toronto

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • PET/MR with 18F-FDG

    Drug

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

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: One arm / exploratory studyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change of FDG uptake of heart

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

Time frame
at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy
2

Change of FDG uptake of lungs

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

Time frame
at 4 weeks prior to radiotherapy, and at 6-10 weeks after completion of radiotherapy
3

Change of the heart function

MRI of ventricular volumes in PETMRI scans

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

Change of the lung perfusion

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

Time frame
before radiotherapy and up to 16 weeks after completion of radiotherapy

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Health Network, Toronto

Lead sponsor

Source ClinicalTrials.gov
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