Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer of the Cervix, Cancer of the Endometrium
- Sponsor
- Duke University
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
Time Frame: 24 months
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 Outcomes
- Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.(24 months)