Initial Feasibility Study To Treat Resectable Pancreatic Cancer With A Planar LDR Source

Study Overview

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

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.

N/A

Pancreas Cancer
Cancer

DEVICE: CivaSheet

CT005

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2017-04-06	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-09-07
First Submitted that Met QC Criteria 2017-04-10	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-09-11
First Posted (ACTUAL) 2017-04-11	Results First Posted N/A	Last Verified 2023-09

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/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 incr	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 ta

Participant Group/Arm

Intervention/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 incr

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 ta

Primary Outcome Measures	Measure Description	Time Frame
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale	Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety & toxicities graded using the CTCAE 4.0 scale.	1.5 years

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Clinical Trial Record