Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

Conditions
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Cancer of the Cervix, Cancer of the Endometrium

Intervention / Treatment
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* Device: Novel nano-scintillator fiber-optic dosimeter (nanoFOD)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real time dosimetric monitoring of brachytherapy.<br> | Device: Novel nano-scintillator fiber-optic dosimeter (nanoFOD)<br>* 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.<br>* Other names: nanoFOD;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months |