GK-ASL: ASL in Brain Metastasis MRI Following Gamma Knife Treatment

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04833335

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Brain Metastases	Other: MRI perfusion sequence	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus Inclusion visit, 1 month later, 6 month later	Other: MRI perfusion sequence Quantitative analysis Other Names: Arterial Spin Labeling (ASL)

Arm

Intervention/Treatment

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

Inclusion visit, 1 month later, 6 month later

Other: MRI perfusion sequence

Quantitative analysis

Other Names:

Arterial Spin Labeling (ASL)

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT04833335

Other Study ID Numbers:

APHP190736

First Posted:

Apr 6, 2021

Last Update Posted:

May 10, 2022

Last Verified:

Jun 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Assistance Publique - Hôpitaux de Paris

Additional relevant MeSH terms:

Neoplasm Metastasis

Neoplasms, Second Primary

Brain Neoplasms

Study Results

No Results Posted as of May 10, 2022