ASL in Brain Metastasis MRI Following Gamma Knife Treatment

Assistance Publique - Hôpitaux de Paris60 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Brain Metastases

Interventions

MRI perfusion sequenceOTHER

Quantitative analysis

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Service de neuroradiologie, hôpital Pitié Salpêtrière

Paris, France

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: Evolution between Baseline MRI, 1 and 6 month follow up MRI

Secondary Outcomes

ASL Perfusion: Cerebral blood flow measurements

Time frame: Baseline MRI, 1 and 6 month follow up MRI

Interreader correlation

Two neuroradiologists

Time frame: Baseline MRI, 1 and 6 month follow-up MRI

Morphological analysis of the lesions

Lesion size, oedema

Time frame: Baseline MRI, 1 and 6 month follow-up MRI

Central Contacts

Natalia SHOR, MD

CONTACT

+330661884335 shor.natalia@icloud.com

Data from ClinicalTrials.gov

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