- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04684862
Infusion System for Hepatic Cancer
Combined Infusion System to Deliver Chemotherapy Regionally to the Liver
This is a single-site, open-label continued access study/treatment protocol under a treatment IDE. In addition to treating patients, the primary objective of this study is to assess the safety of using the Medtronic SynchroMed II programmable pump combined with the Intera tapered catheter for hepatic artery infusion (HAI) of a standard chemotherapy (FUDR) drug for adults with a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to the liver or intrahepatic cholangiocarcinoma.
After successful implantation, the combined pump and catheter system will be evaluated using a nuclear scan in the postoperative period, which is standard procedure to confirm that the pump is functioning prior to HAI of FUDR. Monitoring for safety will include a record of residual pump volume when it is emptied (every 2-12 weeks depending on whether the pump is being used for chemotherapy infusion) to determine if the pump is still working and surveillance of routine cross-sectional imaging (usually every 2-6 months) for any sign of a pump or catheter problem. Patients will be monitored for the safety of the pump/catheter combination for up to 5 years or pump removal/study withdrawal.
Study Overview
Status
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ronald DeMatteo, MD
- Phone Number: 215-662-7539
- Email: Ronald.DeMatteo@pennmedicine.upenn.edu
Study Contact Backup
- Name: Allie Raevsky, MS
- Phone Number: 6092021888
- Email: Allie.Raevsky@Pennmedicine.upenn.edu
Study Locations
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Hospital of the University of Pennsylvania
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Contact:
- Ronald DeMatteo, MD
- Phone Number: 215-662-7539
- Email: Ronald.DeMatteo@pennmedicine.upenn.edu
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Contact:
- Danielle R Jaffe, BS/BA
- Phone Number: 2156944399
- Email: danielle.jaffe@pennmedicine.upenn.edu
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Principal Investigator:
- Ronald DeMatteo, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients must be greater than or equal to 18 years of age
- Have a clinical or biopsy-proven diagnosis of colorectal cancer metastatic to liver or intrahepatic cholangiocarcinoma
- At the time of pump placement, patients will either have unresectable, chemotherapy-responsive disease or they will be undergoing resection with planned postoperative HAI
- Be deemed appropriate for pump chemotherapy by both a medical oncologist and a surgical oncologist
- Provision of signed and dated informed consent form
Exclusion Criteria:
- Known active infection
- Is pregnant or breastfeeding or expecting to conceive children within the projected duration of the trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Hepatic Artery Infusion (HAI) Therapy
Eligible patients will be implanted with a device that combines components of two commercially available drug delivery pumps to administer regional chemotherapy (FUDR) to the liver.
Specifically, a Medtronic pump is being used with an Intera tapered catheter, instead of the Medtronic catheter.
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This infusion system is composed of a Medtronic SynchroMed II programmable pump connected to a Intera tapered catheter.
Specifically, the Medtronic pump comes with a small connector that ends in a metal flange.
During the operation, under sterile conditions, the distal 1 cm of the flange is severed using a scissor.
Then, using a Intera connector pin, the end of the Medtronic catheter is connected to the Intera catheter .
Two 2-0 silk ties secure the catheters to the pin.
The pump and catheter are then inserted into the patient into the abdominal wall or into the chest wall.
The catheter is inserted into an artery within the abdomen (usually the gastroduodenal artery but it depends on the exact arterial branching in the individual patient) that feeds the liver.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Targeted Adverse Events (TAEs)
Time Frame: From surgery up to 60 months post-surgery or study withdrawal
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TAEs are defined as AEs deemed related to the combination of the devices (i.e., the connection between the Medtronic pump and Intera Catheter).
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From surgery up to 60 months post-surgery or study withdrawal
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPCC 19220
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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