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

This study is currently recruiting participants.
Verified April 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02407977
First Posted: April 3, 2015
Last Update Posted: July 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Wallace H. Coulter Foundation
Information provided by (Responsible Party):
Duke University
  Purpose
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.

Condition Intervention
Cancer of the Gastrointestinal, Genitourinary or Gynecologic Systems Other: Novel nano-scintillatorfiber-optic dosimeter ( nanoFOD)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Real Time In-Vivo Body Surface Dosimetry for External Beam Radiation Therapy

Further study details as provided by Duke University:

Primary Outcome Measures:
  • Dosimetric accuracy of the device with reference to a commercially available dosimeter [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: May 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Novel 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.
    Other Name: nanoFOD
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02407977


Contacts
Contact: Tykeytra Dale, BSN MS 919 6683726
Contact: Joan Cahill, BNS OCN CCRP 919 6683726

Locations
United States, North Carolina
Duke University Medica Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Tykeytra Dale, BSN MS    919-668-3726      
Contact: Joan Cahill, BNS OCN CCRP    919 6685211      
Sponsors and Collaborators
Duke University
Wallace H. Coulter Foundation
Investigators
Principal Investigator: Junzo Chino, MD Duke University Health System
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02407977     History of Changes
Other Study ID Numbers: Pro00061601
First Submitted: March 31, 2015
First Posted: April 3, 2015
Last Update Posted: July 11, 2017
Last Verified: April 2017