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

Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03109041

Enrollment

Registered

2017-04-11

Start date

2017-09-06

Completion date

2023-06-30

Last updated

2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pancreas Cancer

Keywords

Whipple, brachytherapy, CivaSheet, CivaTech Oncology, radiation, intraoperative radiation, IORT, resectable pancreatic cancer, Pd-103

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.

Interventions

DEVICECivaSheet

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026