A Phase 1/2 interventional study of Directional Brachytherapy Source Implant in Pancreatic Cancer, sponsored by CivaTech Oncology. Recruiting at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-17.
Sponsored by CivaTech Oncology · Phase 1/2, Interventional, and Treatment
Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.
This is a Feasibility study to determine the safety and efficacy of a new brachytherapy device that provides unidirectional radiation which utilizes active components (Palladium-103) of standard devices in a novel configuration.This pilot study may benefit 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. The appropriate dose and local control rate will be recorded the primary endpoint in order to provide an efficacy assessment.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's planned enrollment of 80 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →CivaTech Oncology is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Subject signed inform consent
Exclusion Criteria:
Patients undergoing a pancreatic cancer resection will receive a CivaSheet LDR directional brachytherapy implant at the time of surgery. 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: Directional Brachytherapy Source Implant
The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton 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 of CivaSheet Radiation Treatement
Patients will be monitored for any adverse radiation toxicity effects from the CivaSheet device.
Time frame: 1 Year
Efficacy of CivaSheet Radiation Treatment
Patients will be monitored for one year to determine the local cancer recurrence rate
Time frame: 1 Year
Morbidity of patients following surgery and radiation
2 year survival rates for patients post surgery and CivaSheet radiation treatment
Time frame: 2 Year
Post Operative Radiation Dosimetry Calculation
Post procedure 3D treatment planning will be performed to determine if the radiation dose delivered was satisfactory
Time frame: 1 Month
Length of Hospital Stay
Length of hospital stay will be monitored to determine if CivaSheet radiation treatment alters the typical length of hospital stay for patients after surgery.
Time frame: 1 Month
Plan to share: No
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CivaTech Oncology