ASL in Brain Metastasis MRI Following Gamma Knife Treatment

Study Overview
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Brief Summary
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Arterial spin labeling (ASL) is a non-invasive MRI technique that could help the radiologists to distinguish brain metastasis progression versus radionecrosis following gamma-knife treatment. The primary target of the study is to establish the diagnostic performances (specificity, sensitivity) of quantitative measures of ASL in brain metastases suspected of progression/radionecrosis after GK treatment

Detailed Description
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The metastasis progression versus radionecrosis following GK treatment can sometimes be difficult to distinguish. 60 patients will be included in this prospective, monocentric study. 3 MRI (baseline, 1month and 6 month follow-ups) will be performed. Two neuroradiologists will blindly analyse the MRIs comparing ASL sensibility and specificity to the standard morphological evaluation and T2 perfusion.

Official Title
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ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.

Conditions
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Brain Metastases

Intervention / Treatment
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* Other: MRI perfusion sequence


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus<br>Inclusion visit, 1 month later, 6 month later | Other: MRI perfusion sequence<br>* Quantitative analysis<br>* Other names: Arterial Spin Labeling (ASL);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic performance of ASL quantitative analysis in brain metastasis following GK treatment : tumor perfusion with quantitative measurement (one value) of RCBF (relative cerebral blood flow) on the ASL sequence | Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after. | Evolution between Baseline MRI, 1 and 6 month follow up MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ASL Perfusion: Cerebral blood flow measurements |  | Baseline MRI, 1 and 6 month follow up MRI | 
| Interreader correlation | Two neuroradiologists | Baseline MRI, 1 and 6 month follow-up MRI | 
| Morphological analysis of the lesions | Lesion size, oedema | Baseline MRI, 1 and 6 month follow-up MRI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ASL, MRI, Metastasis, Gamma knife, Radionecrosis