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NCT Number: NCT04833335

ASL in Brain Metastasis MRI Following Gamma Knife Treatment

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

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Key information

Conditions

Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Nervous System Diseases Nervous System Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service de neuroradiologie, hôpital Pitié Salpêtrière

Paris, 75013, France

Location status: Recruiting

Location contact

Nadya pyatigorskaya, MD

CONTACT

[email protected]

Natalia SHOR, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI perfusion sequence

Other

Quantitative analysis

Other names: Arterial Spin Labeling (ASL)

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

    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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Natalia SHOR, MD

CONTACT

[email protected]

+330661884335

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: GK-ASL

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 6, 2021
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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