ASL in Brain Metastasis MRI Following Gamma Knife Treatment

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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04833335

Acronym

GK-ASL

Enrollment

Registered

2021-04-06

Start date

2023-01-24

Completion date

2028-09-24

Last updated

2025-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Metastases

Keywords

ASL, MRI, Metastasis, Gamma knife, Radionecrosis

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.

Interventions

OTHERMRI perfusion sequence

Quantitative analysis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France

Contacts

Primary ContactNatalia SHOR, MD

shor.natalia@icloud.com+330661884335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026