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

NCT03109041 | Completed Phase 1 FDA Device

• 1 other identifier: CT005
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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

Keywords

Whipple; brachytherapy; CivaSheet; CivaTech Oncology; radiation; intraoperative radiation; IORT; resectable pancreatic cancer; Pd-103

Outcome Measures

Primary Outcomes (1)

• Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale

  Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety \& toxicities graded using the CTCAE 4.0 scale.

  1.5 years

Study Arms (1)

Directional Brachytherapy Source Implant

EXPERIMENTAL

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.

Device: CivaSheet

Interventions

CivaSheet 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.

Directional Brachytherapy Source Implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• CivaTech Oncology: lead

Study Sites (1)

East Carolina University, Brody School of Medicine

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 11, 2017
• Study Start: September 6, 2017
• Primary Completion: December 1, 2022
• Study Completion: June 30, 2023
• Last Updated: September 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)