NCT02407977

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
7 months until next milestone

Study Start

First participant enrolled

November 13, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 19, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2017

Completed
Last Updated

October 22, 2018

Status Verified

October 1, 2018

Enrollment Period

1.4 years

First QC Date

March 31, 2015

Last Update Submit

October 19, 2018

Conditions

Cancer of the Gastrointestinal, Genitourinary or Gynecologic Systems

Outcome Measures

Primary Outcomes (1)

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

    24 months

Secondary Outcomes (1)

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

    24 months

Interventions

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.

Also known as: nanoFOD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects with histologically documented neoplasm of the pelvis (including gynecologic, gastrointestinal, and genitourinary origin).

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duke University Medica Center

Durham, North Carolina, 27710, United States

Location

Study Officials

  • Junzo Chino, MD

    Duke Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2015

First Posted

April 3, 2015

Study Start

November 13, 2015

Primary Completion

April 19, 2017

Study Completion

April 19, 2017

Last Updated

October 22, 2018

Record last verified: 2018-10

Locations

US(1)