NCT04833335

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
26mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress62%
Jan 2023Sep 2028

First Submitted

Initial submission to the registry

March 19, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 6, 2021

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 24, 2023

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 24, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 24, 2028

Last Updated

August 8, 2025

Status Verified

August 1, 2025

Enrollment Period

5.7 years

First QC Date

March 19, 2021

Last Update Submit

August 5, 2025

Conditions

Brain Metastases

Keywords

ASLMRIMetastasisGamma knifeRadionecrosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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

  • Morphological analysis of the lesions

    Baseline MRI, 1 and 6 month follow-up MRI

Study Arms (1)

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

EXPERIMENTAL

Inclusion visit, 1 month later, 6 month later

Other: MRI perfusion sequence

Interventions

MRI perfusion sequenceOTHER

Quantitative analysis

Also known as: Arterial Spin Labeling (ASL)
Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Brain metastasis from histologically proven tumor
  • Lesions suspected of progression/ radionecrosis :
  • i.e.≥ 25% of the size progression
  • Lesion size: gadolinium enhanced part of the tumour ≥1 cm

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de neuroradiologie, hôpital Pitié Salpêtrière

Paris, 75013, France

RECRUITING

MeSH Terms

Conditions

Brain NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Natalia SHOR, MD

CONTACT

+330661884335shor.natalia@icloud.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2021

First Posted

April 6, 2021

Study Start

January 24, 2023

Primary Completion (Estimated)

September 24, 2028

Study Completion (Estimated)

September 24, 2028

Last Updated

August 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)