ASL in Brain Metastasis MRI Following Gamma Knife Treatment (GK-ASL)

Assistance Publique - Hôpitaux de Paris

Status: Enrolling

Conditions: Brain Metastases

Treatments: Other: MRI perfusion sequence

Study type: Interventional

Funder types: Other

Identifiers

NCT04833335

APHP190736

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

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

Experimental group

Description:

Inclusion visit, 1 month later, 6 month later

Treatment:

Other: MRI perfusion sequence