Malignant Liver TumorsPhase 1NCT00869843
Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors
A Phase 1 study testing RF Ablation in people with Malignant Liver Tumors and Liver Metastases From Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball. To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati To determine a safe (non-popping upper limit) of power… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Liver Tumors, Liver Metastases From Colorectal Cancer
- What is being tested?
- RF Ablation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Mar 2009
- Phase
- Phase 1
- 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
Eligibility for Stage I (Normal Liver Tissue)
- Resectable liver metastases from malignant liver tumors, primary or secondary
- Patient has been scheduled for liver resection and is in generally good medical condition
- No evidence of extra-hepatic disease
- Patient does not have a pacemaker
- Age >= 18
- Able to provide informed consent
Eligibility for Stage II (Patients with liver metastases from colorectal cancer)
- Resectable liver metastases from colorectal cancer
- Patient has been scheduled for liver resection is in generally good medical condition
- No evidence of extra-hepatic disease.
- Patient does not have a pacemaker
- Age >= 18
- Able to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Phase I Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors
- To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball.
- To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati
- To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.
Read the detailed description
Treatment Plan: Patients with resectable hepatic metastases confined to the liver and who are referred to the Study Chairs will undergo routine work-up for hepatic resection.
Operative Procedure:
Stage I will be completed and the data analyzed before Stage II commences. Stage I data will be used to define the safe levels for use in Stage II.
Stage I-Depth of coagulation with and without inflow occlusion at fixed times - and powers below the popping threshold.
At surgery, in the absence of extrahepatic disease, the liver will be dissected in the usual fashion for a bi-segmentectomy, hemihepatectomy or larger liver resection. Prior to transection of the liver, saline linked RF ablations will be performed on normal liver tissue within the area of resection away from the tumor and the proposed line of transection.
1 cm and 2 cm diameters will be studied together in 8 patients. They will be treated for a total of 18 minutes (9 min for 1 cm and 9 min for 2 cm with 9 minutes of inflow occlusion. The 4 cm lesions will be studied in 8 other patients, 4 of whom will receive 9 minutes of inflow occlusion.
After resection of the liver and establishment of resection margins on the tumor, the ablated areas of normal liver tissue will be excised frozen and studied for depth of lesion and examined by H \& E and histological techniques using vital stains that will allow definition of tissue depth.
Stage II-An ablate and resect Study
Once parameters have been defined on normal liver, the effect of surface RF ablation on resectable hepatic tumors which come to the surface of the liver will be examined. In this portion of the study, tumors will be treated with saline linked RF ablation with a power and a duration of application which has been found to produce the maximum safe depth of coagulation. The surface area of coagulation will be dependent upon the size of the tumor. The area of treatment will encompass the tumor as well as a zone at least 0.5cm outside the edge of the tumor. Inflow occlusion will be used in one half of the patients.
After resection of the liver and establishment of resection margins on the tumor, the ablated areas will be excised frozen and studied for depth of lesion and examined by H \& E and histological techniques using vital stains that will allow definition of tissue depth. Twelve tumors will be treated in 12 patients.
Pathology Evaluation
First Group of Patients The normal tissue exposed to RF will be resected, prepared for histo-pathological studies and examined to determine the extent of tissue necrosis and popping, if any.
Second Group of Patients Tumors exposed to RF ablation will be resected and the extent of tissue necrosis and popping will be determined. Also, damage to normal tissue will be examined.
- Being tested
- RF Ablation
- Keywords
- Metastatic colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RF AblationProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Single group | Other | Not described Receives: Procedure: RF Ablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball
On day of surgery
Measured: Day 1
Efficacy of the technique on surface liver tumors using saline lined RF Surface ablation.
On day of surgery
Measured: Day 1
Secondary outcomes (1)
Determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion and a 2 cm depth with inflow occlusion.
On day of surgery
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2009 (estimated)
- Study startOct 2002
- Primary completionOct 2007
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Malignant Liver TumorsStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Strasberg, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00869843
- Sponsor's protocol ID
- 02-0343
- Status last verified
- Apr 2013
- First submitted
- 25 Mar 2009
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Gnerlich JL, Ritter JH, Linehan DC, Hawkins WG, Strasberg SM. Saline-linked surface radiofrequency ablation: a safe and effective method of surface ablation of hepatic metastatic colorectal cancer. Ann Surg. 2009 Jul;250(1):96-102. doi: 10.1097/SLA.0b013e3181ae91af.
PubMed 19561459
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Saline Linked Monopolar Surface Radiofrequency (RF) Ablation of Hepatic Tumors
- ClinicalTrials.gov ID
- NCT00869843
- Acronym / sponsor ID
- 02-0343
- Keywords
- Metastatic colorectal cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Oct 2007 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Mar 2009 (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.
- To determine the depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball.
- To determine the efficacy of the technique on surface liver tumors using saline linked RF surface ablati
- To determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion an da 2 cm depth with inflow occlusion.
Detailed description
Treatment Plan: Patients with resectable hepatic metastases confined to the liver and who are referred to the Study Chairs will undergo routine work-up for hepatic resection.
Operative Procedure:
Stage I will be completed and the data analyzed before Stage II commences. Stage I data will be used to define the safe levels for use in Stage II.
Stage I-Depth of coagulation with and without inflow occlusion at fixed times - and powers below the popping threshold.
At surgery, in the absence of extrahepatic disease, the liver will be dissected in the usual fashion for a bi-segmentectomy, hemihepatectomy or larger liver resection. Prior to transection of the liver, saline linked RF ablations will be performed on normal liver tissue within the area of resection away from the tumor and the proposed line of transection.
1 cm and 2 cm diameters will be studied together in 8 patients. They will be treated for a total of 18 minutes (9 min for 1 cm and 9 min for 2 cm with 9 minutes of inflow occlusion. The 4 cm lesions will be studied in 8 other patients, 4 of whom will receive 9 minutes of inflow occlusion.
After resection of the liver and establishment of resection margins on the tumor, the ablated areas of normal liver tissue will be excised frozen and studied for depth of lesion and examined by H \& E and histological techniques using vital stains that will allow definition of tissue depth.
Stage II-An ablate and resect Study
Once parameters have been defined on normal liver, the effect of surface RF ablation on resectable hepatic tumors which come to the surface of the liver will be examined. In this portion of the study, tumors will be treated with saline linked RF ablation with a power and a duration of application which has been found to produce the maximum safe depth of coagulation. The surface area of coagulation will be dependent upon the size of the tumor. The area of treatment will encompass the tumor as well as a zone at least 0.5cm outside the edge of the tumor. Inflow occlusion will be used in one half of the patients.
After resection of the liver and establishment of resection margins on the tumor, the ablated areas will be excised frozen and studied for depth of lesion and examined by H \& E and histological techniques using vital stains that will allow definition of tissue depth. Twelve tumors will be treated in 12 patients.
Pathology Evaluation
First Group of Patients The normal tissue exposed to RF will be resected, prepared for histo-pathological studies and examined to determine the extent of tissue necrosis and popping, if any.
Second Group of Patients Tumors exposed to RF ablation will be resected and the extent of tissue necrosis and popping will be determined. Also, damage to normal tissue will be examined.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Other | Procedure: RF Ablation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| RF Ablation | Procedure or surgery | Single group |
Primary outcome
Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball
Time frame: Day 1
On day of surgery
Efficacy of the technique on surface liver tumors using saline lined RF Surface ablation.
Time frame: Day 1
On day of surgery
1 secondary outcome
Determine a safe (non-popping upper limit) of power per area that will permit a 1 cm depth of tissue destruction without inflow occlusion and a 2 cm depth with inflow occlusion.
Time frame: Day 1
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 23 Apr 2013.
- Derived from this study: PubMed 19561459Gnerlich JL, Ritter JH, Linehan DC, Hawkins WG, Strasberg SM. Saline-linked surface radiofrequency ablation: a safe and effective method of surface ablation of hepatic metastatic colorectal cancer. Ann Surg. 2009 Jul;250(1):96-102. doi: 10.1097/SLA.0b013e3181ae91af.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
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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.
Steven Strasberg, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RF Ablation in people with Malignant Liver Tumors and Liver Metastases From Colorectal Cancer, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 23 Apr 2013. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Depth of coagulation which is possible in human liver tissue using the saline linked RF Surface ablation with the Tissue Link floating ball (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00869843, which also lists 1 linked publication.
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 23 Apr 2013.