- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03109041
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
September 7, 2023 updated by: CivaTech Oncology
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Greenville, North Carolina, United States, 27834
- East Carolina University, Brody School of Medicine
-
-
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.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
Time Frame: 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.
|
1.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 Major Dates
Study Start (Actual)
September 6, 2017
Primary Completion (Actual)
December 1, 2022
Study Completion (Actual)
June 30, 2023
Study Registration Dates
First Submitted
April 6, 2017
First Submitted That Met QC Criteria
April 10, 2017
First Posted (Actual)
April 11, 2017
Study Record Updates
Last Update Posted (Actual)
September 11, 2023
Last Update Submitted That Met QC Criteria
September 7, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
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
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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