Recruiting
Phase 1
Phase 2

CivaSheet

Sponsor:

CivaTech Oncology

Code:

NCT02843945

Conditions

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Directional Brachytherapy Source Implant

Study Details

Brief summary:

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.

Conditions

Pancreatic Cancer

Study ID

NCT02843945

Start date

May 31, 2017

Status verified date

Jun, 2025

Completion date

Oct 30, 2028

Anticipated

Primary completion date

Oct 29, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Subject signed inform consent

  • Age > 18 years
  • Not pregnant or breast feeding
  • Patient capable of undergoing anesthesia
  • Patient selected to undergo Whipple procedure or distal pancreatectomy
  • Patient does not have metastatic disease
  • Patients will have close margins
  • No prior radiation therapy to the region for separate cancer
  • Confirmed diagnosis of borderline resectable or locally advanced pancreatic adenocarcinoma
  • Patient Received neoadjuvant chemoradiation (4-10 weeks prior to surgery)
  • Chemotherapy was administered for 2-6 cycles with any combination of the following agents:
  • Gemcitabine + nb-paclitaxel
  • FOLFIRINOX
  • Neoadjuvant Chemoradiation was administered as IMRT or 3DCRT (up to 56 Gy), or SBRT (up to 36 Gy) with Pre-operative External beam dose (NCCN)
  • up to 56 Gy (1.8-2.0 Gy per fractions) with concurrent gemcitabine, capecitabine, or infusional 5-fluorouracil

Exclusion Criteria:

  • Not surgical candidate
  • Any other invasive cancer in the past 5 years, except basal cell or squamous cell skin cancer
  • An IRE candidate (IRE is Percutaneous irreversible electroporation)
  • Recurrent or previously resected tumors
  • Documented History of Alcoholism and or drug abuse
  • Participant in other clinical trials

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Directional Brachytherapy Source Implant

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.

Interventions

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.

Primary outcome measure

  • Safety of CivaSheet Radiation Treatement [ Time Frame: 1 Year ]

Central Contacts and Locations

Central contacts

Carra Castagnero

919-314-5515ccastagnero@civatechoncology.com

Kristy Perez, PhD

9193145515kperez@civatechoncology.com

Locations

Advocate Christ Medical Center

Recruiting

Oak Lawn, Illinois, United States, 60453

Contacts

Colleen Valenti, OCN

708-684-4694colleen.valenti@advocatehealth.com

Principal Investigator:

Paul Crossan, MD

More Information

Sponsor

CivaTech Oncology

Last update posted

Jun 17, 2025

Last verified

Jun, 2025

Keywords

  • brachytherapy
  • CivaSheet
  • CivaTech
  • whipple
  • radiation
  • borderline resectable
  • locally advanced
  • Pd-103
  • intraoperative radiation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by CivaTech Oncology on 2025-06-17.