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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03109041
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : January 15, 2019
Information provided by (Responsible Party):
CivaTech Oncology

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 disease Intervention/treatment Phase
Pancreas Cancer Cancer Device: CivaSheet Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 : September 6, 2017
Estimated Primary Completion Date : March 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

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.
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.

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03109041

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Contact: Carra Castagnero 9193145515
Contact: Kristy Perez, PhD 6789545744

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United States, North Carolina
East Carolina University, Brody School of Medicine Recruiting
Greenville, North Carolina, United States, 27834
Contact: Renee Coghill    252-744-5723    COGHILLL@ECU.EDU   
Contact: Amanda Wetherington    252-744-5723      
Principal Investigator: Emmanuel Zervos         
Sub-Investigator: Andrew Ju         
Sponsors and Collaborators
CivaTech Oncology

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Responsible Party: CivaTech Oncology Identifier: NCT03109041    
Other Study ID Numbers: CT005
First Posted: April 11, 2017    Key Record Dates
Last Update Posted: January 15, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
CivaTech Oncology
intraoperative radiation
resectable pancreatic cancer
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases