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Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

Primary Purpose

Cancer of the Cervix, Cancer of the Endometrium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Novel nano-scintillator fiber-optic dosimeter (nanoFOD)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Cancer of the Cervix, Cancer of the Endometrium

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Duke Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Real time dosimetric monitoring of brachytherapy.

Arm Description

Outcomes

Primary Outcome Measures

Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
This will only be possible in a subset of women whose implant geometry will result in a radially symmetric dose cloud (i.e. vaginal cylinder cases) so that both the nanoFOD and the reference dosimeter may be placed in a position expected to have the same, or closely similar dose.

Secondary Outcome Measures

Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
Feasibility in this context will mean ease of clinical use (subjective), lack of device failures, and accordance of the nanoFOD dosimetric reading with the planned dose as calculated by the planning software.

Full Information

First Posted
January 16, 2014
Last Updated
May 4, 2017
Sponsor
Duke University
Collaborators
Wallace H. Coulter Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02040155
Brief Title
Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Official Title
Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
Wallace H. Coulter Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Cervix, Cancer of the Endometrium

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Real time dosimetric monitoring of brachytherapy.
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Novel nano-scintillator fiber-optic dosimeter (nanoFOD)
Other Intervention Name(s)
nanoFOD
Intervention Description
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 Outcome Measure Information:
Title
Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
Description
This will only be possible in a subset of women whose implant geometry will result in a radially symmetric dose cloud (i.e. vaginal cylinder cases) so that both the nanoFOD and the reference dosimeter may be placed in a position expected to have the same, or closely similar dose.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
Description
Feasibility in this context will mean ease of clinical use (subjective), lack of device failures, and accordance of the nanoFOD dosimetric reading with the planned dose as calculated by the planning software.
Time Frame
24 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junzo Chino, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

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Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

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