---
title: Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.
nct_id: NCT02732769
overall_status: COMPLETED
phase: NA
sponsor: Assistance Publique Hopitaux De Marseille
study_type: INTERVENTIONAL
primary_condition: Lung Cancer
countries: France
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02732769.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02732769"
ct_last_update_post_date: 2018-10-03
last_seen_at: "2026-05-12T06:19:54.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Clinical Evaluation of the Treatment of Intellectual Metastases by Radiosurgery Gamma Knife by Means of a Support System by Mask.

**NCT ID:** [NCT02732769](https://clinicaltrials.gov/study/NCT02732769)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 58
- **Lead Sponsor:** Assistance Publique Hopitaux De Marseille
- **Conditions:** Lung Cancer, Brain Metastases
- **Start Date:** 2016-02
- **Completion Date:** 2018-03-21
- **CT.gov Last Update:** 2018-10-03

## Brief Summary

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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Group treated by radiosurgery with stereotaxic frame** (ACTIVE_COMPARATOR) — Subjects will receive a radiosurgery during a brief hospitalization by LeksellGammaKnifePerfexion® (LGKP)
- **Group treated by radiosurgery with the thermoformed mask** (EXPERIMENTAL) — Subjects will receive a radiosurgery with thermoformed mask during a brief hospitalization by GammaKnifeICON® (GKI) with Efficast®

## Interventions

- **GammaKnifePerfexion®** (DEVICE) — neurosurgery
- **GammaKnifeIcon®** (DEVICE) — neurosurgery
- **Efficast®** (DEVICE) — Thermoformed mask
- **MRI** (DEVICE)

## Primary Outcomes

- **Evaluation of pain during the hospitalization (3 days)** _(time frame: 12 months)_ — Questionary (numeric pain intensity scale)

## Secondary Outcomes

- **Evaluation of tumor control at 3 months** _(time frame: 12 months)_
- **Evaluation of tumor control at 6 months** _(time frame: 12 months)_
- **Occurrence of clinical side effects** _(time frame: 12 months)_

## Locations (1)

- Assistance Publique Hôpitaux de Marseille, Marseille, France

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.assistance publique hôpitaux de marseille|marseille||france` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02732769.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02732769*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*