Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

Cancer of the Cervix, Cancer of the Endometrium Clinical Trial

Official title:

Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040155
• Other study ID #: Pro00050297
• Status: Completed
• Phase: N/A
• First received: January 16, 2014
• Last updated: May 4, 2017
• Start date: February 2014
• Est. completion date: August 2015

Study information

• Verified date: May 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Brachytherapy is a curative treatment for many malignancies, brachytherapy delivers a high radiation dose to a very small and well-specified target within a patient with cancer. Yet there is no current convenient, inexpensive, real time method of confirming the radiation dose delivered. There is no current monitoring or fail-safe device for radiation oncologists and their patients if the radiation dose becomes too high, especially to radiation sensitive organs, or conversely if the target receives too little dose.High dose-rate(HDR) brachytherapy is a highly advanced radiation-based cancer treatment, where a very small radioactive source, Iridium-192, is placed in or near the tumor through a catheter or channel. This provides a high radiation dose to the tumor in 5-15 minutes with a precise location, while minimizing radiation exposure to surrounding tissue and organs. 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 radiation therapy treatments. The size of the device allows placement through a catheter or channel near areas of interest, or within already placed brachytherapy delivery catheters.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Any clinical scenario in which the nanoFOD placement or reading would compromise the treatment efficacy, or endanger the patient in any way.

Related Conditions & MeSH terms

• Cancer of the Cervix, Cancer of the Endometrium
• Endometrial Neoplasms
• Uterine Cervical Neoplasms

Intervention

Device:
• Novel nano-scintillator fiber-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 the real time dosimetric monitoring of brachytherapy treatment.

Locations

Country	Name	City	State
United States	Duke Cancer Center	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Wallace H. Coulter Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.	Feasibility in this context will mean ease of clinical use (subjective), lack of device failures, and accordance of the nanoFOD dosimetric reading with the planned dose as calculated by the planning software.	24 months