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Recruiting NCT04833335

ASL in Brain Metastasis MRI Following Gamma Knife Treatment

No phase Interventional Brain Metastases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MRI perfusion sequence.
Who it may be relevant to
Registry conditions: Brain Metastases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other MRI perfusion sequence
    Quantitative analysis

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 [Time frame: Evolution between Baseline MRI, 1 and 6 month follow up MRI]
Secondary outcome measures (3)
  • ASL Perfusion: Cerebral blood flow measurements [Time frame: Baseline MRI, 1 and 6 month follow up MRI]
  • Interreader correlation [Time frame: 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]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

France · 1 center
  • Service de neuroradiologie, hôpital Pitié Salpêtrière — Paris

Identifiers

NCT: NCT04833335 · APHP190736

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗