Carcinoma, HepatocellularNCT00392366
Laser Interstitial Thermal Therapy Under "Real Time" MRI Guidance for "Minimal Invasive" Treatment of Liver Metastasis
A study testing MR-guided Laser Interstitial Thermal Therapy System in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by BioTex, Inc. at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Hepatocellular, Liver Neoplasms, Digestive System Neoplasms
- What is being tested?
- MR-guided Laser Interstitial Thermal Therapy System
- Type of treatment
- Medical device
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2006to Jul 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
Read the detailed description
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.
- Being tested
- MR-guided Laser Interstitial Thermal Therapy System
- Keywords
- MRI guided Laser Therapy, Laser Interstitial Thermal Therapy, Magnetic Resonance Thermal Imaging, Liver Metastasis
- Medical subject headings
- Carcinoma, Hepatocellular, Liver Neoplasms, Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-guided Laser Interstitial Thermal Therapy SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of predicted lesion geometry to histologically measured dimensions
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2006 (estimated)
- Study startJul 2006
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, HepatocellularStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioTex, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Paul Legmann, M.D., Principal investigator, Cochin Hosptial, Paris, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00392366
- Sponsor's protocol ID
- LITT / METASTASE HEPATIQUES
- Status last verified
- Dec 2009
- First submitted
- 24 Oct 2006
- Last updated
- 1 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00392366
- Acronym / sponsor ID
- LITT / METASTASE HEPATIQUES
- Keywords
- MRI guided Laser Therapy, Laser Interstitial Thermal Therapy, Magnetic Resonance Thermal Imaging, Liver Metastasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- BioTex, Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Jul 2008 (actual)
- First posted
- 26 Oct 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-guided Laser Interstitial Thermal Therapy System | Device | – |
Primary outcome
Accuracy of predicted lesion geometry to histologically measured dimensions
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Legmann, M.D. principal investigator
Cochin Hosptial, Paris, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MR-guided Laser Interstitial Thermal Therapy System in people with Carcinoma, Hepatocellular and Liver Neoplasms, run by BioTex, Inc. at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of predicted lesion geometry to histologically measured dimensions. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2010.