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OpenTrials
Completed

NCT Number: NCT00392366

Laser Interstitial Thermal Therapy Under "Real Time" MRI Guidance for "Minimal Invasive" Treatment of Liver Metastasis

The purpose of this study is to determine if the, MR guided, laser interstitial thermal therapy (LITT) treatment technique can be safety and efficiently used for the human liver metastasis

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Cochin

Paris, 75679, France

About this study

This new "minimally invasive" technique has been tested so far, with success, on animal brain and prostate tumors. LITT has also tested with success by other teams for the treatment of liver metastasis.

The main purpose of this study is to determine if the Visualase, MR guided, laser interstitial thermal therapy device can be safely and efficiently used for the treatment of human liver metastasis originating from the colon and rectal primary tumors.

As secondary objectives for this clinical study is to explore the tolerance of the treatment and its contra indications.

The clinical trial will include a statistical sample of 25 patients and will run over a period of 24 months. The inclusion period will be of 12 months and the patients will be followed up during a period of 7 days after the intervention.

The clinical trial will be performed at the Cochin University Hospital of Paris and the patients will be coming from the oncology / surgery departments of the hospital.

The patients recruited for this study are those who developed several liver metastasis and are planned for the a surgical resection for part of the liver (where metastasis are located). Prior to the surgical resection, a LITT procedure will be performed on one of the metastasis. After the surgical resection histological analysis will be elaborated to compare the real necrosis volume created by the LITT procedure to the expected predicted volume.

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 liver metastasis, originating from colon and liver cancer and proved by histological analysis
  • Patient that are scheduled for a surgical resection of part of the liver,
  • Patient having a liver metastasis, originating from colon and rectal cancer, smaller or equal to 3 cm
  • Patients having the liver metastasis at a distance of at least 1 cm or from the hepatic capsule or/and from a vascular structure

Exclusion criteria

  • Patients younger than 18 years old
  • Patients presenting contra indication for MRI studies
  • Patient presenting contra indication to liver surgery
  • Patients who already had other interstitial treatment on the targeted lesion

Treatment and study plan

MR-guided Laser Interstitial Thermal Therapy System

Device

Primary outcomes

  1. Accuracy of predicted lesion geometry to histologically measured dimensions

Sponsors and collaborators

Lead sponsor

BioTex, Inc.

Industry

Registry information

Official study title

The Clinical Evaluation of the Laser Interstitial Thermal Therapy (LITT ), Under "Real Time" MRI Guidance, for the "Minimal Invasive" Treatment of Liver Metastasis - a Phase IIa Mono-centric Study, Without Direct Benefice to the Patient

Important dates

Study start
2006
Study completion
2008
First posted
Oct 26, 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.

Published trials that share one or more normalized conditions with this study.