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

Primary Purpose

Brain Metastases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI perfusion sequence
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Metastases focused on measuring ASL, MRI, Metastasis, Gamma knife, Radionecrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Service de neuroradiologie, hôpital Pitié SalpêtrièreRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm Description

Inclusion visit, 1 month later, 6 month later

Outcomes

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
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
Interreader correlation
Two neuroradiologists
Morphological analysis of the lesions
Lesion size, oedema

Full Information

First Posted
March 19, 2021
Last Updated
February 1, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT04833335
Brief Title
ASL in Brain Metastasis MRI Following Gamma Knife Treatment
Acronym
GK-ASL
Official Title
ASL in Diagnostics of Tumor Progression Versus Radionecrosis in Brain Metastasis Following Gamma Knife Treatment.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 24, 2023 (Actual)
Primary Completion Date
January 24, 2025 (Anticipated)
Study Completion Date
January 24, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Metastases
Keywords
ASL, MRI, Metastasis, Gamma knife, Radionecrosis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults with brain metastases treated with Gamma Knife whose lesions suggest tumor recurrence versus
Arm Type
Experimental
Arm Description
Inclusion visit, 1 month later, 6 month later
Intervention Type
Other
Intervention Name(s)
MRI perfusion sequence
Other Intervention Name(s)
Arterial Spin Labeling (ASL)
Intervention Description
Quantitative analysis
Primary Outcome Measure Information:
Title
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
Description
Quantitative analysis (rCBF) of the evolution of brain metastasis between the initiation of treatment and 6 months after.
Time Frame
Evolution between Baseline MRI, 1 and 6 month follow up MRI
Secondary Outcome Measure Information:
Title
ASL Perfusion: Cerebral blood flow measurements
Time Frame
Baseline MRI, 1 and 6 month follow up MRI
Title
Interreader correlation
Description
Two neuroradiologists
Time Frame
Baseline MRI, 1 and 6 month follow-up MRI
Title
Morphological analysis of the lesions
Description
Lesion size, oedema
Time Frame
Baseline MRI, 1 and 6 month follow-up MRI

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalia SHOR, MD
Phone
+330661884335
Email
shor.natalia@icloud.com
Facility Information:
Facility Name
Service de neuroradiologie, hôpital Pitié Salpêtrière
City
Paris
ZIP/Postal Code
75013
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Natalia SHOR, MD
Email
natalia.shor@aphp.fr
First Name & Middle Initial & Last Name & Degree
Nadya pyatigorskaya, MD
Email
nadya.pyatigorskaya@aphp.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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ASL in Brain Metastasis MRI Following Gamma Knife Treatment

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