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

C

CivaTech Oncology

Status and phase

Completed
Phase 1

Conditions

Pancreas Cancer
Cancer

Treatments

Device: CivaSheet

Study type

Interventional

Funder types

Industry

Identifiers

NCT03109041
CT005

Details and patient eligibility

About

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.

Enrollment

2 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2 participants in 1 patient group

Directional Brachytherapy Source Implant
Experimental group
Description:
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.
Treatment:
Device: CivaSheet

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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