Evaluating heart and lung function before and after radiotherapy using advanced imaging
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
NA · University Health Network, Toronto · NCT04901884
This study is testing how radiotherapy affects heart and lung function in patients with chest cancers to better understand any problems it might cause.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto (other) |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04901884 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of radiotherapy on cardiopulmonary function in patients with thoracic malignancies, specifically focusing on pulmonary hypertension. It employs hybrid PET/MRI imaging to simultaneously assess molecular, anatomical, and functional aspects of the cardiopulmonary system. By correlating imaging biomarkers with plasma metabolomics, the study aims to identify the underlying causes of radiation-induced cardiopulmonary dysfunction. The goal is to enhance the understanding of how radiotherapy affects heart and lung health in these patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a clinically proven thoracic malignant mass scheduled for radiotherapy that involves incidental cardiac irradiation.
Not a fit: Patients with contraindications for MRI or Gadolinium injection, or those who are pregnant or breastfeeding, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and management of cardiopulmonary dysfunction in patients undergoing radiotherapy.
How similar studies have performed: While the use of PET/MRI in this specific context is novel, similar imaging approaches have shown promise in other studies evaluating cardiopulmonary function.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (RECRUITING)
Study contacts
- Principal investigator: Patrick Veit-Haibach, MD — University Health Network, Toronto
- Study coordinator: Patrick Veit-Haibach, MD
- Email: Patrick.Veit-Haibach@uhn.ca
- Phone: 416-340-4800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pulmonary Hypertension