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Completed

NCT Number: NCT00392119

MR Guided Laser Interstitial Thermal Therapy for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors

The purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for human brain metastasis and primary brain tumors.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital Lariboisiere

Paris, 75475, France

About this study

This new "minimally invasive" technique has been tested so far, with success, on animal brain tumor models and on human liver metastasis.

The main purpose of this study is to determine if the stereotactic, MR guided, laser interstitial thermal therapy treatment technique can be safety and efficiently used for the human brain metastasis and primary brain tumors.

As secondary objectives for this clinical study, the following are to be explored:

  • Eventual evaluation of the eventual mid and long term post-intervention complications,
  • Evaluate the contra indication for the technique,
  • Evaluate and optimize clinical and logistic intervention protocols,
  • Evaluate the mean duration for the procedure,
  • Evaluate the mean cost for the procedure

The clinical trial will include a statistical sample of 12-18 treatments and will run over a period of 18 months. The inclusion period will be for 6 months and the patients will be followed up during 12 months post intervention.

The clinical trial will be performed at the Lariboisiere University Hospital of Paris and the patients will be coming from all the Assistance Publique de Paris ( APHP ) hospitals

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years of age or older
  • Patients with brain metastasis located in the brain hemispheres
  • Patient with a brain metastasis smaller or equal to 4 cm in diameter
  • Patient with primary brain tumor smaller or equal to 4 cm in diameter
  • Patient previously treated with other therapeutic techniques ( radio-therapy, chemotherapy, immunotherapy) which have failed.

Exclusion criteria

  • Patients less than 18 years old,
  • Patients presenting contra indication for MRI studies
  • Patient for which the primary cancer is melanoma or kidney tumors
  • Patients having a mean life duration longer than 3 months (due to the primary cancer)

Treatment and study plan

MR-guided Laser Interstitial Thermal Therapy System

Device

Primary outcomes

  1. 12 month morbidity and mortality

Secondary outcomes

  1. Mid and long term post-intervention complications,

  2. Contra indication for the technique,

  3. Optimize clinical and logistic intervention protocols,

  4. Mean procedure duration

  5. Mean procedure cost

Sponsors and collaborators

Lead sponsor

BioTex, Inc.

Industry

Registry information

Official study title

The Clinical Evaluation of the Stereotactic, MR Guided, Laser Interstitial Thermal Therapy (LITT ) for the "Minimal Invasive" Treatment of Brain Metastasis and Primary Brain Tumors - a Phase I Study With Direct Patient Benefice

Important dates

Study start
2006
Study completion
2008
First posted
Oct 25, 2006
Registry last updated
Jan 1, 2010

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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