Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
This trial has been completed.
|Condition||cancer of the cervix, cancer of the endometrium|
|Treatment||novel nano-scintillator fiber-optic dosimeter (nanofod)|
|Collaborator||Wallace H. Coulter Foundation|
|Start date||February 2014|
|End date||August 2015|
|Trial size||16 participants|
|Trial identifier||NCT02040155, Pro00050297|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
time frame: 24 months
Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
time frame: 24 months
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.
|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.|
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