Using brain imaging to predict treatment response in patients with brain metastases
Imaging Trial of Biomarkers to Guide Individualized Therapy in Patients With Brain Metastasis Receiving Radiotherapy
This study is testing if brain scans can help predict how well patients with brain metastases will respond to radiation treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT04197297 on ClinicalTrials.gov |
What this trial studies
This study focuses on patients with brain metastases who are scheduled to receive radiation treatment. Participants will undergo CT and MRI scans before and after their treatment to measure specific biomarkers that may indicate how well they will respond to the therapy. The goal is to validate the predictive abilities of these imaging biomarkers, which could help tailor treatment plans for better outcomes. Conducted at the Princess Margaret Cancer Center, this single-center phase II study aims to enroll up to 90 patients over a two-year period.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with biopsy-proven primary malignancies and brain metastases who are planned for radiation treatment.
Not a fit: Patients who have previously undergone whole brain radiotherapy or radiosurgery to the index lesion may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment personalization for patients with brain metastases, enhancing their response to radiation therapy.
How similar studies have performed: Previous studies have suggested that imaging biomarkers can predict treatment response, indicating that this approach has potential based on earlier findings.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Biopsy proven primary malignancy (original biopsy is adequate as long as the brain imaging is consistent with brain metastases) * At least one index lesion with diameter \> 1cm and without imaging evidence of hemorrhage * Patients age \> 18 years of age * Patients planned for RT to brain metastases * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Previous Whole Brain Radiotherapy * Previous radiosurgery to the index lesion * Individuals unable to undergo contrasted MRI for whatever reason
Where this trial is running
Toronto, Ontario
- University Health Network — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Catherine Coolens, Ph. D — Princess Margaret Cancer Center - UHN
- Study coordinator: David Shultz, M.D., Ph. D
- Email: david.shultz@rmp.uhn.on.ca
- Phone: 416-946-6899
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.