ASL in Brain Metastasis MRI Following Gamma Knife Treatment

NCT ID: NCT04833335

Last Updated: 2025-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2028-09-24

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.

Conditions

Brain Metastases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus

Inclusion visit, 1 month later, 6 month later

Group Type: EXPERIMENTAL

MRI perfusion sequence

Intervention Type: OTHER

Quantitative analysis

Interventions

MRI perfusion sequence

Quantitative analysis

Intervention Type: OTHER

Other Intervention Names

Arterial Spin Labeling (ASL)

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Service de neuroradiologie, hôpital Pitié Salpêtrière

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Natalia SHOR, MD

Role: CONTACT

shor.natalia@icloud.com

+330661884335

Facility Contacts

Natalia SHOR, MD

Role: primary

natalia.shor@aphp.fr

Nadya pyatigorskaya, MD

Role: backup

nadya.pyatigorskaya@aphp.fr

Other Identifiers

APHP190736

Identifier Type: -

Identifier Source: org_study_id