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

August 5, 2025 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
Evolution between Baseline MRI, 1 and 6 month follow up MRI

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2023

Primary Completion (Estimated)

September 24, 2028

Study Completion (Estimated)

September 24, 2028

Study Registration Dates

First Submitted

March 19, 2021

First Submitted That Met QC Criteria

April 2, 2021

First Posted (Actual)

April 6, 2021

Study Record Updates

Last Update Posted (Actual)

August 8, 2025

Last Update Submitted That Met QC Criteria

August 5, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP190736

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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