Cancer of the Gastrointestinal, Genitourinary or Gynecologic Systems
Conditions
Brief summary
This is an observational study. 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 external beam delivery of radiation therapy treatments.This new protocol is similiar in design to Pro00050297 with the significant difference being the monitoring will be performed during external baem radiotherapy.
Detailed description
The device is currently in use in an ongoing IRB approved protocol Pro00050297 Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy. Brachytherapy is an integral part of the management of many gynecological cancers, which uses radioactive isotopes to deliver radiation treatment in close proximity to the target. The protocol uses the device in the setting of gynecologic brachytherapy to monitor real time doses, with a primary endpoint of feasibility and accuracy. Accrual is ongoing, however, the device has initially given consistent results, within 3% of the expected values. This initial experience is intentionally designed with the simplest geometry and positioning. This protocol has a similar design to the initial brachytherapy trial, but with the significant difference that the monitoring will be performed during external beam radiotherapy. Calibration procedures are different in this scenario, and the considerations of when and where dose monitoring will be useful are distinct from these considerations in brachytherapy.
Interventions
OTHERNovel nano-scintillatorfiber-optic dosimeter ( nanoFOD)
This is an observational study whose purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter ( nanoFOD) for real time dosimetric monitoring of external beam radiotherapy.
Sponsors
Wallace H. Coulter Foundation
Duke University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin). * Planned external beam radiotherapy as part of standard of care treatment * The radiotherapy plan involves the body surface * Age \> 18 years * Able to provide and execute informed consent
Exclusion criteria
* Allergy or previous intolerance of skin adhesives * Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dosimetric accuracy of the device with reference to a commercially available dosimeter | 24 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of clinical application of the nanaoFOD for dosimetric monitoring of external beam radiotherapy. | 24 months | Feasibility in this context will mean ease of clinical use (subjective) and lack of device failures. |
Countries
United States
Outcome results
None listed