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

Part of paid clinical trials in Tampa, Florida.

Sponsor
CivaTech Oncology
Study ID
NCT02843945
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Directional Brachytherapy Source Implant — DEVICE
    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.

Study Details

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.

Key Dates

Start date
May 31, 2017
Status verified
Jun 2025
Primary completion
Oct 29, 2027
Completion
Oct 30, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Tampa General HospitalTampaFlorida33612
Raegen Einsmann
[email protected]
813-974-7247
Timothy Nywening, MD (PRINCIPAL_INVESTIGATOR)
Rush University Cancer CenterChicagoIllinois60612-
Advocate Christ Medical CenterOak LawnIllinois60453
Colleen Valenti, OCN
[email protected]
708-684-4694
Paul Crossan, MD (PRINCIPAL_INVESTIGATOR)
Marc Mesleh, MD (SUB_INVESTIGATOR)
University Medical Center LSUNew OrleansLouisiana70112-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
Virginia Commonwealth University Massey Cancer CenterRichmondVirginia23298-

Find similar trials in Tampa, FL

By condition
Pancreatic cancer
By specialty
OncologyGI oncology
By research site
Tampa General Hospital· Tampa, FLRush University Cancer Center· Chicago, ILAdvocate Christ Medical Center· Oak Lawn, ILUniversity Medical Center LSU· New Orleans, LAFox Chase Cancer Center· Philadelphia, PAVirginia Commonwealth University Massey Cancer Center· Richmond, VA

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