Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
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|ClinicalTrials.gov Identifier: NCT03109041|
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : January 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Pancreas Cancer Cancer||Device: CivaSheet||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03109041
|Contact: Carra Castagnerofirstname.lastname@example.org|
|Contact: Kristy Perez, PhDemail@example.com|
|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|