Using MRI to Differentiate Between Brain Metastasis Progression and Radionecrosis After Gamma Knife Treatment
Official title: ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.
Run by Assistance Publique - Hôpitaux de Paris · NCT04833335 · Data updated 2026-11-12
This study is testing a new MRI method to see if it can help tell the difference between brain cancer growth and treatment side effects in patients who have had gamma knife therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Status | Recruiting |
| Started | January 24, 2023 |
| Main results expected | September 24, 2028 |
| Study ends | September 24, 2028 |
| Registry record updated | August 8, 2025 |
| Trial ID | NCT04833335 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with brain metastases from histologically proven tumors who have received gamma knife treatment within the last four months.
✕Probably not a fit
Patients with a history of primary brain tumors, those who are pregnant, or individuals with MRI incompatibility will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effectiveness of arterial spin labeling (ASL), a non-invasive MRI technique, in distinguishing between brain metastasis progression and radionecrosis in patients who have undergone gamma knife treatment. A total of 60 patients will participate, undergoing three MRI scans at baseline, one month, and six months post-treatment. Two neuroradiologists will analyze the MRI results to compare the sensitivity and specificity of ASL against standard morphological evaluations and T2 perfusion imaging. The goal is to improve diagnostic accuracy for patients with suspected changes in their brain metastases.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses for patients with brain metastases, allowing for better treatment decisions.
How similar studies have gone: While the use of ASL in this specific context is novel, similar imaging techniques have shown promise in other studies for differentiating between types of brain lesions.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Brain metastasis from histologically proven tumor * GK treatment within 4 month prior to the inclusion * Lesions suspected of progression/ radionecrosis : i.e.≥ 25% of the size progression * Lesion size: gadolinium enhanced part of the tumour ≥1 cm Exclusion Criteria: * Pregnancy * Medical history of primitive brain tumour * MRI incompatibility/ medical history of contrast agent allergy * Claustrophobia * Patient unable to consent * Epilepsia/recent stroke * Patients participating in other studies * Patients without health care insurance
Where it's running
-
Service de neuroradiologie, hôpital Pitié Salpêtrière
Paris, France Recruiting
Study contacts
- Study coordinator: Natalia SHOR, MD
- Email: shor.natalia@icloud.com
- Phone: +330661884335
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.