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

NCT ID: NCT03109041

Last Updated: 2023-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-06
• Study Completion Date: 2023-06-30

Brief Summary

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.

Conditions

Pancreas Cancer; Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CivaSheet

Intervention Type: DEVICE

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.

Interventions

CivaSheet

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CivaTech Oncology

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

East Carolina University, Brody School of Medicine

Greenville, North Carolina, United States

Countries

United States

Other Identifiers

CT005

Identifier Type: -

Identifier Source: org_study_id