Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
1 other identifier
interventional
16
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 16, 2014
CompletedFirst Posted
Study publicly available on registry
January 20, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedMay 5, 2017
May 1, 2017
1.5 years
January 16, 2014
May 4, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
24 months
Study Arms (1)
Real time dosimetric monitoring of brachytherapy.
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke Universitylead
- Wallace H. Coulter Foundationcollaborator
Study Sites (1)
Duke Cancer Center
Durham, North Carolina, 27710, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Junzo Chino, MD
Duke Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 16, 2014
First Posted
January 20, 2014
Study Start
February 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2015
Last Updated
May 5, 2017
Record last verified: 2017-05