Pulmonary HypertensionNCT04901884
PET/MR Pre- and Post Radiotherapy for Cardiopulmonary Dysfunction Evaluation
A study testing PET/MR with 18F-FDG in people with Pulmonary Hypertension, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- PET/MR with 18F-FDG
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2021to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
University Health Network
Toronto, Ontario, M5G 2M9
Patrick Veit-Haibach
About this study
Official title: Exploratory Evaluation of Simultaneous Cardiac PET/MR, Metabolomic Markers and Circulating DNA as Possible Prognostic Markers in Identifying Patients Developing Transient or Permanent Cardiopulmonary Dysfunctions After Radiotherapy
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).
Read more
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.
- Conditions
- Pulmonary Hypertension
- Being tested
- PET/MR with 18F-FDG
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR with 18F-FDGDrug
(18F) Fluorodeoxyglucose (FDG) will be administered by intravenous injection at a dose of 4-5 MBq/kg.
| Study group | Role | What they receive |
|---|---|---|
| One arm / exploratory study | Experimental | Injection of 18F-FDG.The 18F-FDG cardiac PET-MR scanning visit will take up to 1.5 hours. Receives: Drug: PET/MR with 18F-FDG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of FDG uptake of heart
FDG uptake of the left and right ventricles of heart will be measured and compared in PETMRI scans
Measured: 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
Measured: 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
Measured: 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
Measured: before radiotherapy and up to 16 weeks after completion of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start1 Jun 2021
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Biopsy or otherwise clinically proven thoracic malignant mass which is intended to be treated with radio(chemo)therapy
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Veit-Haibach, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901884
- Sponsor's protocol ID
- 18-5879
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2021
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Evaluation of Simultaneous Cardiac PET/MR, Metabolomic Markers and Circulating DNA as Possible Prognostic Markers in Identifying Patients Developing Transient or Permanent Cardiopulmonary Dysfunctions After Radiotherapy
- ClinicalTrials.gov ID
- NCT04901884
- Acronym / sponsor ID
- 18-5879
- Conditions
- Pulmonary Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Biopsy or otherwise clinically proven thoracic malignant mass which is intended to be treated with radio(chemo)therapy
| Arm | Type | Receives |
|---|---|---|
| One arm / exploratory study | Experimental | Drug: PET/MR with 18F-FDGInjection of 18F-FDG.The 18F-FDG cardiac PET-MR scanning visit will take up to 1.5 hours. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MR with 18F-FDG(18F) Fluorodeoxyglucose (FDG) will be administered by intravenous injection at a dose of 4-5 MBq/kg. | Drug | One arm / exploratory study |
Primary outcome
Change of FDG uptake of heart
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Veit-Haibach, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR with 18F-FDG in people with Pulmonary Hypertension, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Veit-Haibach, MD (416-340-4800 ext. 6085, Patrick.Veit-Haibach@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.