Clinical trial · Interventional
Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
the Mask fixation isn't a new solution for the immobilization of the patient's head and has been used in current practice for long years. This trial is attempting to compare these two technical possibilities of head fixation by mask or by stereotaxic frame. The primary goal is to evaluate the comfort for the patient and specifically for each step of the procedure. It will also evaluate other parameters such as the effectiveness of these two strategies and tolerance.The expected benefit is an improvement of the comfort for the patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Brain Metastases | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Efficast® | Device | — | UNRESOLVED |
| GammaKnifeIcon® | Device | — | UNRESOLVED |
| GammaKnifePerfexion® | Device | — | UNRESOLVED |
| MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Group treated by radiosurgery with stereotaxic frame
- description
- Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
- interventionNames
- Device: GammaKnifePerfexion®
- Device: MRI
- type
- EXPERIMENTAL
- label
- Group treated by radiosurgery with the thermoformed mask
- description
- Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®
- interventionNames
- Device: GammaKnifeIcon®
- Device: Efficast®
- Device: MRI
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject bearing of one to five intellectual metastases of lung origin at the time of the indication of the radiosurgery * Subject requiring a radiosurgical treatment with LGK Exclusion Criteria: * Subject having hurts of the brainstem or para-optics * Pregnant women or in feeding period * Subject having received previously a whole brain radiotherapy
References
Publications (0)
Data not yet available