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RecruitingNCT04901884Updated Oct 5, 2026

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

An interventional study of PET/MR with 18F-FDG in Pulmonary Hypertension, sponsored by University Health Network, Toronto. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Jun 2021; still recruiting 5 years 4 months later.
Updated Oct 5, 2026Primary completion movedStudy completion movedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

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.

Read the detailed description

RT is a well-known and established therapy or adjuvant therapy for the treatment of thoracic malignancies (breast cancer, lung cancer, lymphoma and others). It usually uses high energy radiation from x-rays, gamma rays or other charged particles to induce DNA damage in malignant cells. Despite the measures taken to reduce the total radiation dose and to limit the radiation to normal tissues, the signs and symptoms of radiation induced cardiopulmonary dysfunction (RICPD) still persist. However, in the majority of cases, it remains unclear which cardiopulmonary damage is the main /leading cause for the clinical symptoms the patients are experiencing.

Hybrid PET/MRI is a promising technique that allows for truly simultaneous molecular, anatomic and functional imaging of the cardiopulmonary system. The simultaneity is an important aspect in this proposed study since only parameters measured at the same time in PET and MR can be used for an integrated, multimodality parameter for possible detection and prognostication of the different underlying processes of cardiopulmonary dysfunction after RT. Furthermore, certain PET-uptake of the RV have to be corrected for RV mass which is only possible with concomitant anatomical imaging. MR imaging and PET at different time point are not accurately reflective of the underlying pathophysiological pathways and metabolic state at the specific time points pre- and post radiotherapy. To our knowledge, there are no online publications of its use in the diagnosis and prognostication of cardiopulmonary dysfunction after RT and specifically PH.

02

Conditions studied

  • Pulmonary Hypertension
03

In context

Hypertension, Pulmonary

1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.

This study's planned enrollment of 40 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.

Browse Hypertension, Pulmonary studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study 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.

    Drug: PET/MR with 18F-FDG

Interventions

  • DrugPET/MR with 18F-FDG

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
  • University Health Network
    Toronto, Ontario M5G 2M9, Canada
    • Patrick Veit-Haibach · Contact
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Primary completion
Jun 1, 2026→Sep 1, 2027
Oct 5, 2026
Study completion
Jun 1, 2026→Sep 1, 2027
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Primary completion Jun 1, 2026→Sep 1, 2027
    Study completion Jun 1, 2026→Sep 1, 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04901884
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
May 26, 2021
Start date
Jun 1, 2021
Primary completion
Sep 1, 2027 (estimated)
Completion
Sep 1, 2027 (estimated)
Last update
Oct 5, 2026

Study contacts

Patrick Veit-Haibach, MD
Contact
Patrick.Veit-Haibach@uhn.ca
416-340-4800 ext. 6085
Andrew Hope, MD
Contact
Andrew.Hope@rmp.uhn.ca
416-946-2124
Patrick Veit-Haibach, MD
principal investigator · University Health Network, Toronto

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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