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OpenTrials
Completed

NCT Number: NCT02407977

Real Time In-Vivo Body Surface Dosimetry for External Beam Radiation Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Medica Center

Durham, North Carolina, 27710, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Novel nano-scintillatorfiber-optic dosimeter ( nanoFOD)

Other

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.

Other names: nanoFOD

Primary outcomes

  1. Dosimetric accuracy of the device with reference to a commercially available dosimeter

    Time frame: 24 months

Secondary outcomes

  1. Feasibility of clinical application of the nanaoFOD for dosimetric monitoring of external beam radiotherapy.

    Time frame: 24 months

    Feasibility in this context will mean ease of clinical use (subjective) and lack of device failures.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Wallace H. Coulter Foundation

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 3, 2015
Registry last updated
Oct 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.