Actively Recruiting
ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-08
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of arterial spin labeling (ASL), a non-invasive MRI technique, to help radiologists differentiate between brain metastasis progression and radionecrosis after gamma-knife treatment. The study focuses on assessing the diagnostic accuracy, including sensitivity and specificity, of quantitative ASL measures in patients with brain metastases suspected of progression or radionecrosis. The trial includes 60 patients in a prospective, single-center design. Participants will undergo three MRI scans: at baseline, one month, and six months after inclusion. The MRI includes ASL sequences for quantitative analysis of cerebral blood flow. Two neuroradiologists will independently and blindly analyze the MRIs to compare ASL's diagnostic performance with standard morphological MRI evaluations and T2 perfusion imaging. During the study, participants will attend an inclusion visit and follow-up visits at one and six months. Researchers will measure tumor perfusion using relative cerebral blood flow values from the ASL sequences across these time points. Secondary assessments include inter-reader agreement and morphological lesion analysis. The study monitors participants through these visits to gather imaging data and evaluate ASL's diagnostic utility in distinguishing tumor progression from radionecrosis.
CONDITIONS
Brief Title
ASL in Brain Metastasis MRI Following Gamma Knife Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Brain metastasis from histologically proven tumor
- Gamma Knife treatment within 4 months prior to inclusion
- Lesions suspected of progression or radionecrosis with at least 25% size progression
- Lesion size of gadolinium-enhanced tumor part at least 1 cm
You will not qualify if you...
- Pregnancy
- History of primitive brain tumor
- MRI incompatibility or allergy to contrast agent
- Claustrophobia
- Unable to provide consent
- Epilepsy or recent stroke
- Participation in other clinical studies
- No health care insurance coverage
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants undergo MRI scans to evaluate tumor progression versus radionecrosis using ASL perfusion sequences and standard morphological assessments.
3 MRI visits at baseline, 1 month, and 6 months (in-person)
Trial Site Locations
Total: 1 location
1
Service de neuroradiologie, hôpital Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
N
Natalia SHOR, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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