NCT04197297 Brain Imaging Biomarkers in Patients With Brain Metastasis
| NCT ID | NCT04197297 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Health Network, Toronto |
| Condition | Brain Metastases, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 90 participants |
| Start Date | 2021-10-05 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 90 participants in total. It began in 2021-10-05 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A biomarker is a measurable indicator of the severity or presence of some disease state. In this study, brain metastases patients who will be receiving radiation treatment, will undergo CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scans prior to and after radiation treatment to measure these biomarkers. This is a single-center phase II study to validate the predictive abilities of biomarkers, in terms of determining how patients will respond to radiation treatment.
Eligibility 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
Contact & Investigator
Catherine Coolens, Ph. D
PRINCIPAL INVESTIGATOR
Princess Margaret Cancer Center - UHN
Frequently Asked Questions
Who can join the NCT04197297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04197297 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04197297 currently recruiting?
Yes, NCT04197297 is actively recruiting participants. Contact the research team at david.shultz@rmp.uhn.on.ca for enrollment information.
Where is the NCT04197297 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT04197297 clinical trial?
NCT04197297 is sponsored by University Health Network, Toronto. The principal investigator is Catherine Coolens, Ph. D at Princess Margaret Cancer Center - UHN. The trial plans to enroll 90 participants.