ASL in Brain Metastasis MRI Following Gamma Knife Treatment

Not Applicable

Recruiting

• Conditions: Brain Metastases
• Interventions: Other: MRI perfusion sequence

• Registration Number: NCT04833335
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-04-02
• Study First Posted: 2021-04-06
• Study Start: 2023-01-24
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-07
• Last Update Posted: 2024-06-10
• Primary Completion: 2026-01-24
• Study Completion: 2026-01-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus	MRI perfusion sequence	Inclusion visit, 1 month later, 6 month later

Primary Outcome Measures

Name	Time	Method
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	Evolution between Baseline MRI, 1 and 6 month follow up MRI	Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Service de neuroradiologie, hôpital Pitié Salpêtrière; 🇫🇷 Paris, France