Infusion System for Hepatic Cancer

Last updated: October 14, 2024
Sponsor: Ronald DeMatteo, M.D.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Cancer

Biliary Tract Cancer

Digestive System Neoplasms

Treatment

Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)

Clinical Study ID

NCT04684862
UPCC 19220
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 liveror intrahepatic cholangiocarcinoma

  • At the time of pump placement, patients will either have unresectable,chemotherapy-responsive disease or they will be undergoing resection with plannedpostoperative HAI

  • Be deemed appropriate for pump chemotherapy by both a medical oncologist and asurgical oncologist

  • Provision of signed and dated informed consent form

Exclusion

Exclusion Criteria:

  • Known active infection

  • Is pregnant or breastfeeding or expecting to conceive children within the projectedduration of the trial

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)
Phase:
Study Start date:
February 08, 2021
Estimated Completion Date:
July 31, 2029

Connect with a study center

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

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