Liver CancerNCT00782886
Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer
An observational study of Liver Cancer, run by Pathfinder Therapeutics at 3 sites in United States.
Trial summary
Image-guided surgery essentially describes the interactive use of medical images during a surgical procedure and is often referred to as a "global positioning" system (GPS) for surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Nov 2010
- Phase
- Observational
- 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
Study population: Participants receiving surgery for Liver disease.
Who may be able to join
- Written informed consent must be obtained.
- Patient must be 18 years or older.
- Patients recruited are male or non-pregnant, non-lactating females. Liver resection or ablation could be harmful to an unborn child, and therefore is not recommended during pregnancy. All consented patients of childbearing potential will be advised to use adequate birth control (oral, implanted, or barrier methods), along with their sexual partners, while being considered for liver tumor resection or ablation and one month following surgery.
- Negative serum or urine pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
- Patients enrolled must be candidates for surgical liver resection of liver cancer (primary or metastatic) or benign liver lesions (hemangioma, Focal Nodular Hyperplasia, Adenoma). Liver cancer must be present on preoperative imaging study (CT and/or MRI), if applicable.
- Patient must be scheduled for surgical treatment of the liver cancer requiring the removal of at least one (1) anatomic segment.
- -
Who cannot join
- Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- Patients that have a mental condition rendering them unable to understand informed consent to the nature, scope, and possible consequences of this study.
- Patients requiring surgical intervention that extends beyond the liver, with the exception that extension into some adjacent structures might be allowed unless the liver is not the primary focus of the surgery AND the potential blood loss from the other surgical sites may jeopardize the safety of the patient. There is no absolute rule as to what adjacent structures would be allowed, thus prior approval must be obtained from the Medical Monitor listed above for all extrahepatobiliary surgery.
- Patients with hereditary hematologic/coagulation disorders unrelated to their liver disease.
- Patients with cirrhosis of the liver classified as Child's B or C. (See Appendix A)
- Use of aspirin within 7 days prior to surgery or antiplatelet agents (i.e., Plavix) within 10 days prior to surgery or nonsteroidal anti-inflammatory medications within 48 hours prior to surgery.
Show all 13Show fewer
- Patients with thrombocytopenia (platelet counts below 100,000 per ml, White Count 3.0, Hemoglobin 10 or greater).
- Patients who are currently (within the last 30 days prior to surgery) participating in another clinical trial with any investigational drug or device.
- Patients undergoing liver surgery as a result of trauma.
- Patients undergoing liver surgery for the purpose of receiving a liver transplant.
- Patients undergoing liver surgery in which there is a single minor wedge resection on the surface of the liver.
- Patients with established renal insufficiency (defined as creatinine greater than 2.5 mg/dl), or a condition that requires hemodialysis.
- -
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Florida Department of Surgery
Gainesville, Florida, 32610
Memorial Sloan Kettering Cancer Center
New York, New York, 10021
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Image-guided surgery essentially describes the interactive use of medical images during a surgical procedure and is often referred to as a "global positioning" system (GPS) for surgery.
Read the detailed description
In an automobile GPS, the current position of a vehicle is accurately localized or "registered" onto an electronic roadmap located on the dashboard. As the automobile moves, its position is updated on this roadmap. The driver can use the GPS as a guide to determine where the vehicle has been and where it is headed. This same concept is applied during image-guided surgery, as the current surgical position of instruments in the operating room is registered onto medical images of the patient acquired preoperatively. These images are used as a guide by the surgeon for more accurate localization of tumors and other surrounding anatomic structures. This clinical trial is designed to determine the effectiveness of using image-guided techniques for the treatment of liver tumors.
- Conditions
- Liver Cancer
- Keywords
- Pathfinder, Liver, Resection, Surgery, To evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery., Completeness of resection and the accuracy of the resection, as determined by preoperative predicted RLV
- Medical subject headings
- Liver Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall purpose of this NIH-funded study is to evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2008 (estimated)
- Study startApr 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pathfinder Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Investigators
- David Geller, M.D., Principal investigator, UPMC Liver Cancer CenterWilliam Jarnagin, MD, Principal investigator, Memorial Sloan Kettering Cancer CenterAlan Hemming, M.D., Principal investigator, University of Florida Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00782886
- Sponsor's protocol ID
- PTI-LC-2007-01
- Other IDs
- R44CA119502
- Status last verified
- Jan 2011
- First submitted
- 28 Oct 2008
- Last updated
- 27 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Image-Guided Liver Surgical System for Resection of Liver Cancer
- ClinicalTrials.gov ID
- NCT00782886
- Acronym / sponsor ID
- PTI-LC-2007-01
- Conditions
- Liver Cancer
- Keywords
- Pathfinder, Liver, Resection, Surgery, To evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery., Completeness of resection and the accuracy of the resection, as determined by preoperative predicted RLV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Pathfinder TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Apr 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 31 Oct 2008 (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.
Image-guided surgery essentially describes the interactive use of medical images during a surgical procedure and is often referred to as a "global positioning" system (GPS) for surgery.
Detailed description
In an automobile GPS, the current position of a vehicle is accurately localized or "registered" onto an electronic roadmap located on the dashboard. As the automobile moves, its position is updated on this roadmap. The driver can use the GPS as a guide to determine where the vehicle has been and where it is headed. This same concept is applied during image-guided surgery, as the current surgical position of instruments in the operating room is registered onto medical images of the patient acquired preoperatively. These images are used as a guide by the surgeon for more accurate localization of tumors and other surrounding anatomic structures. This clinical trial is designed to determine the effectiveness of using image-guided techniques for the treatment of liver tumors.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants receiving surgery for Liver disease.
Key inclusion criteria (7 listed)
- Written informed consent must be obtained.
- Patient must be 18 years or older.
- Patients recruited are male or non-pregnant, non-lactating females. Liver resection or ablation could be harmful to an unborn child, and therefore is not recommended during pregnancy. All consented patients of childbearing potential will be advised to use adequate birth control (oral, implanted, or barrier methods), along with their sexual partners, while being considered for liver tumor resection or ablation and one month following surgery.
- Negative serum or urine pregnancy test result at screening in women of childbearing potential (applies to patients without documented menopause or sterility).
- Patients enrolled must be candidates for surgical liver resection of liver cancer (primary or metastatic) or benign liver lesions (hemangioma, Focal Nodular Hyperplasia, Adenoma). Liver cancer must be present on preoperative imaging study (CT and/or MRI), if applicable.
Key exclusion criteria (13 listed)
- Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
- Patients that have a mental condition rendering them unable to understand informed consent to the nature, scope, and possible consequences of this study.
- Patients requiring surgical intervention that extends beyond the liver, with the exception that extension into some adjacent structures might be allowed unless the liver is not the primary focus of the surgery AND the potential blood loss from the other surgical sites may jeopardize the safety of the patient. There is no absolute rule as to what adjacent structures would be allowed, thus prior approval must be obtained from the Medical Monitor listed above for all extrahepatobiliary surgery.
- Patients with hereditary hematologic/coagulation disorders unrelated to their liver disease.
- Patients with cirrhosis of the liver classified as Child's B or C. (See Appendix A)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The overall purpose of this NIH-funded study is to evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery.
Time frame: 24 Months
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 27 Jan 2011.
- Pathfinder TherapeuticsLink provided by the sponsor.
- Medelis Inc. (CRO)Link 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.
David Geller, M.D. principal investigator
UPMC Liver Cancer Center
William Jarnagin, MD principal investigator
Memorial Sloan Kettering Cancer Center
Alan Hemming, M.D. principal investigator
University of Florida Department of Surgery
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Cancer, run by Pathfinder Therapeutics at 3 sites 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?
The sponsor lists 7 inclusion and 13 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 27 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
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?
The overall purpose of this NIH-funded study is to evaluate the effectiveness of image-guided liver surgery by measuring variables before, during and following surgery. (time frame: 24 Months). 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 27 Jan 2011.