Overview

This trial has been completed.

Condition cancer of the cervix, cancer of the endometrium
Treatment novel nano-scintillator fiber-optic dosimeter (nanofod)
Sponsor Duke University
Collaborator Wallace H. Coulter Foundation
Start date February 2014
End date August 2015
Trial size 16 participants
Trial identifier NCT02040155, Pro00050297

Summary

This is an observational study. The purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of brachytherapy treatment. Women with gynecologic cancers treated with brachytherapy as part of their standard therapeutic regimen will represent the study population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Arm
(Experimental)
novel nano-scintillator fiber-optic dosimeter (nanofod) nanoFOD
This is an observational study whose purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of brachytherapy treatment.

Primary Outcomes

Measure
Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
time frame: 24 months

Secondary Outcomes

Measure
Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
time frame: 24 months

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Histologically documented neoplasm of the female genital tract. - Planned brachytherapy as part of standard of care treatment. - Age > 18 years - Able to provide and execute informed consent Exclusion Criteria: - Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.

Additional Information

Official title Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Principal investigator Junzo Chino, MD
Description Brachytherapy is a curative treatment for many malignancies, brachytherapy delivers a high radiation dose to a very small and well-specified target within a patient with cancer. Yet there is no current convenient, inexpensive, real time method of confirming the radiation dose delivered. There is no current monitoring or fail-safe device for radiation oncologists and their patients if the radiation dose becomes too high, especially to radiation sensitive organs, or conversely if the target receives too little dose.High dose-rate(HDR) brachytherapy is a highly advanced radiation-based cancer treatment, where a very small radioactive source, Iridium-192, is placed in or near the tumor through a catheter or channel. This provides a high radiation dose to the tumor in 5-15 minutes with a precise location, while minimizing radiation exposure to surrounding tissue and organs. 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 radiation therapy treatments. The size of the device allows placement through a catheter or channel near areas of interest, or within already placed brachytherapy delivery catheters.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Duke University.