ASL in Brain Metastasis MRI Following Gamma Knife Treatment

Brain Metastases Clinical Trial

— GK-ASL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04833335
• Other study ID #: APHP190736
• Status: Recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: January 24, 2026

Study information

• Verified date: June 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Natalia SHOR, MD
• Phone: +330661884335
• Email: shor.natalia[@]icloud.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 24, 2026
• Est. primary completion date: January 24, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Metastases
• Brain Neoplasms
• Neoplasm Metastasis

Intervention

Other:
• MRI perfusion sequence
Quantitative analysis

Locations

Country	Name	City	State
France	Service de neuroradiologie, hôpital Pitié Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ASL Perfusion: Cerebral blood flow measurements		Baseline MRI, 1 and 6 month follow up MRI
Secondary	Interreader correlation	Two neuroradiologists	Baseline MRI, 1 and 6 month follow-up MRI
Secondary	Morphological analysis of the lesions	Lesion size, oedema	Baseline MRI, 1 and 6 month follow-up MRI