Clinical trial NCT02040155: Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Official title: Real Time In-Vivo Dosimetry For Gynecologic Brachytherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer of the Cervix, Cancer of the Endometrium
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Wallace H. Coulter Foundation
First posted: 2014-01-20
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measure dosimetric accuracy of the device with reference to a commercially available dosimeter.
timeFrame: 24 months
Secondary outcomes:
measure: Confirm feasibility of clinical application of the nanoFOD for dosimetric monitoring of brachytherapy with complex geometry implants.
timeFrame: 24 months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Cancer Center
state: North Carolina
Study officials:
affiliation: Duke Health
name: Junzo Chino, MD
role: PRINCIPAL_INVESTIGATOR
References: