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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03109041
Other study ID # CT005
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 6, 2017
Est. completion date June 30, 2023

Study information

Verified date September 2023
Source CivaTech Oncology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 2
Est. completion date June 30, 2023
Est. primary completion date December 1, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
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.

Locations

Country Name City State
United States East Carolina University, Brody School of Medicine Greenville North Carolina

Sponsors (1)

Lead Sponsor Collaborator
CivaTech Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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