NCT00392366

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

January 1, 2010

Status Verified

December 1, 2009

First QC Date

October 24, 2006

Last Update Submit

December 30, 2009

Conditions

Carcinoma, HepatocellularLiver NeoplasmsDigestive System Neoplasms

Keywords

MRI guided Laser TherapyLaser Interstitial Thermal TherapyMagnetic Resonance Thermal ImagingLiver Metastasis

Outcome Measures

Primary Outcomes (1)

  • Accuracy of predicted lesion geometry to histologically measured dimensions

Interventions

MR-guided Laser Interstitial Thermal Therapy SystemDEVICE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Cochin

Paris, 75679, France

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver NeoplasmsDigestive System Neoplasms

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Paul Legmann, M.D.

    Cochin Hosptial, Paris, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

July 1, 2006

Study Completion

July 1, 2008

Last Updated

January 1, 2010

Record last verified: 2009-12

Locations

FR(1)