Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source

Sponsor
CivaTech Oncology (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03109041
Collaborator
(none)
12
Enrollment
1
Location
1
Arm
75.8
Anticipated Duration (Months)
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.

Condition or DiseaseIntervention/TreatmentPhase
  • Device: CivaSheet
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
Actual Study Start Date :
Sep 6, 2017
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

ArmIntervention/Treatment
Experimental: Directional Brachytherapy Source Implant

Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.

Device: CivaSheet
The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.

Outcome Measures

Primary Outcome Measures

  1. Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale [1.5 years]

    Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Subject signed informed consent

  • Age >/= 18 years

  • Biopsy confirmed adenocarcinoma pancreatic cancer

  • Patient capable of undergoing anesthesia

  • Patient is a surgical candidate

  • Patient selected to undergo pancreatic cancer resection

  • Patient will have known or suspected close/positive surgical margin

  • Confirmed diagnosis of resectable pancreatic adenocarcinoma

  • Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle

Exclusion Criteria:
  • Pregnant or breast feeding

  • Patient has metastatic disease

  • Patient has had prior radiation therapy to the region for separate cancer

  • Patient has had prior chemotherapy

  • Any other invasive cancer in the past 5 years, except basal cell skin

  • Recurrent or previously resected tumors

  • Alcoholism/Drug abuse

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1East Carolina University, Brody School of MedicineGreenvilleNorth CarolinaUnited States27834

Sponsors and Collaborators

  • CivaTech Oncology

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
CivaTech Oncology
ClinicalTrials.gov Identifier:
NCT03109041
Other Study ID Numbers:
  • CT005
First Posted:
Apr 11, 2017
Last Update Posted:
Mar 2, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by CivaTech Oncology
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2022