Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID04833335

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

Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-08

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the use of arterial spin labeling (ASL), a non-invasive MRI technique, to help radiologists differentiate between brain metastasis progression and radionecrosis after gamma-knife treatment. The study focuses on assessing the diagnostic accuracy, including sensitivity and specificity, of quantitative ASL measures in patients with brain metastases suspected of progression or radionecrosis. The trial includes 60 patients in a prospective, single-center design. Participants will undergo three MRI scans: at baseline, one month, and six months after inclusion. The MRI includes ASL sequences for quantitative analysis of cerebral blood flow. Two neuroradiologists will independently and blindly analyze the MRIs to compare ASL's diagnostic performance with standard morphological MRI evaluations and T2 perfusion imaging. During the study, participants will attend an inclusion visit and follow-up visits at one and six months. Researchers will measure tumor perfusion using relative cerebral blood flow values from the ASL sequences across these time points. Secondary assessments include inter-reader agreement and morphological lesion analysis. The study monitors participants through these visits to gather imaging data and evaluate ASL's diagnostic utility in distinguishing tumor progression from radionecrosis.

CONDITIONS

Brief Title

ASL in Brain Metastasis MRI Following Gamma Knife Treatment

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Brain metastasis from histologically proven tumor
  • Gamma Knife treatment within 4 months prior to inclusion
  • Lesions suspected of progression or radionecrosis with at least 25% size progression
  • Lesion size of gadolinium-enhanced tumor part at least 1 cm
Not Eligible

You will not qualify if you...

  • Pregnancy
  • History of primitive brain tumor
  • MRI incompatibility or allergy to contrast agent
  • Claustrophobia
  • Unable to provide consent
  • Epilepsy or recent stroke
  • Participation in other clinical studies
  • No health care insurance coverage

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Diagnostic Evaluation

Duration - 6 months

Participants undergo MRI scans to evaluate tumor progression versus radionecrosis using ASL perfusion sequences and standard morphological assessments.

3 MRI visits at baseline, 1 month, and 6 months (in-person)

Trial Site Locations

Total: 1 location

1

Service de neuroradiologie, hôpital Pitié Salpêtrière

Paris, France, 75013

Actively Recruiting

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Research Team

N

Natalia SHOR, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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