Real Time In-Vivo Body Surface Dosimetry for External Beam Radiation Therapy

This is an observational study. This protocol will determine the feasibility of using a novel nano-material based fiber-optic dosimeter (nanoFOD) device, with dimensions less than 1 mm wide, to measure real-time, pin-point, in-vivo radiation dose given during external beam delivery of radiation therapy treatments.This new protocol is similiar in design to Pro00050297 with the significant difference being the monitoring will be performed during external baem radiotherapy.

Study Overview

• Status: Completed
• Conditions: Cancer of the Gastrointestinal, Genitourinary or Gynecologic Systems
• Intervention / Treatment: Other: Novel nano-scintillatorfiber-optic dosimeter ( nanoFOD)

Detailed Description

The device is currently in use in an ongoing IRB approved protocol Pro00050297 "Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy". Brachytherapy is an integral part of the management of many gynecological cancers, which uses radioactive isotopes to deliver radiation treatment in close proximity to the target. The protocol uses the device in the setting of gynecologic brachytherapy to monitor real time doses, with a primary endpoint of feasibility and accuracy. Accrual is ongoing, however, the device has initially given consistent results, within 3% of the expected values. This initial experience is intentionally designed with the simplest geometry and positioning. This protocol has a similar design to the initial brachytherapy trial, but with the significant difference that the monitoring will be performed during external beam radiotherapy. Calibration procedures are different in this scenario, and the considerations of when and where dose monitoring will be useful are distinct from these considerations in brachytherapy.

• Study Type: Observational
• Enrollment (Actual): 13

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medica Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects with histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).

Description

Inclusion Criteria:

• Histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).
• Planned external beam radiotherapy as part of standard of care treatment
• The radiotherapy plan involves the body surface
• Age > 18 years
• Able to provide and execute informed consent

Exclusion Criteria:

• Allergy or previous intolerance of skin adhesives
• Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Dosimetric accuracy of the device with reference to a commercially available dosimeter	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of clinical application of the nanaoFOD for dosimetric monitoring of external beam radiotherapy.	Feasibility in this context will mean ease of clinical use (subjective) and lack of device failures.	24 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Wallace H. Coulter Foundation
• Investigators: Principal Investigator: Junzo Chino, MD, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2015
• Primary Completion (Actual): April 19, 2017
• Study Completion (Actual): April 19, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (Estimate): April 3, 2015

Study Record Updates

• Last Update Posted (Actual): October 22, 2018
• Last Update Submitted That Met QC Criteria: October 19, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Pro00061601