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

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ClinicalTrials.gov Identifier: NCT04833335
Recruitment Status : Not yet recruiting
First Posted : April 6, 2021
Last Update Posted : June 16, 2021
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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.
Estimated Study Start Date : August 15, 2021
Estimated Primary Completion Date : February 15, 2022
Estimated Study Completion Date : August 15, 2023
Arms and Interventions
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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 Name: Arterial Spin Labeling (ASL)


Outcome Measures
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Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. ASL Perfusion: Cerebral blood flow measurements [ Time Frame: Baseline MRI, 1 and 6 month follow up MRI ]
  2. Interreader correlation [ Time Frame: Baseline MRI, 1 and 6 month follow-up MRI ]
    Two neuroradiologists

  3. Morphological analysis of the lesions [ Time Frame: Baseline MRI, 1 and 6 month follow-up MRI ]
    Lesion size, oedema


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833335


Contacts
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Contact: Natalia SHOR, MD +330661884335 shor.natalia@icloud.com

Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT04833335    
Other Study ID Numbers: APHP190736
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: June 16, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
ASL
MRI
Metastasis
Gamma knife
Radionecrosis
Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplasms, Second Primary
Brain Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
 Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases