Trial Outcomes & Findings for Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study (NCT NCT01706705)

Last Updated: 2022-02-23

Results Overview

To determine the number of participants with improved image quality using the Novel Brachytherapy Applicator, using subjective and objective measures. In the subjective, for assessment of image quality for clinical use, the images obtained in the "shifted" position and in the "standard" position, were compared by a radiation oncologist without knowledge of which was the first and which was the second image. To provide and objective measure of the reduction in image artifact with the shields shifted, the bladder, rectum, and sigmoid were contoured, and average and standard deviation of Hounsfield units (HU) within these critical structures on the images were compared.

Recruitment status

COMPLETED

Study phase

Target enrollment

57 participants

Primary outcome timeframe

At the time of implant

Results posted on

2022-02-23

Participant Flow

Participant milestones

Participant milestones
Measure	Experimental Brachytherapy Treatment Planning Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
Overall Study STARTED	57
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Experimental Brachytherapy Treatment Planning Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
Overall Study Death	1
Overall Study Lack of Efficacy	13
Overall Study Non-clinical	6

Baseline Characteristics

Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Experimental Brachytherapy Treatment Planning n=37 Participants Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	35 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age, Continuous	40 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants

PRIMARY outcome

Timeframe: At the time of implant

Outcome measures

Outcome measures
Measure	Experimental Brachytherapy Treatment Planning n=15 Participants Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
Number of Participants With Improved Image Quality in the Shifted Position Standard Position	0 Participants
Number of Participants With Improved Image Quality in the Shifted Position Shifted Position	15 Participants

SECONDARY outcome

Timeframe: At the time of implant

Population: The adaptive applicator fit into 15 of the evaluated patients so the analysis was limited to these 15 patients.

The number of participants with high quality images of the bladder, rectum and sigmoid with the adaptive applicator in the shifted position and standard position assessed by the Hounsfield unit values. The higher quality images are the images with higher density when the applicator is in either the shifted or standard position. The Hounsfield unit (HU) is a relative quantitative measurement of radio density used by radiologists in the interpretation of computed tomography (CT) images. The images obtained in the "shifted" position and in the "standard" position with the use of the adaptive applicator, were compared by a radiation oncologist without knowledge of which was the first and which was the second image.

Outcome measures

Outcome measures
Measure	Experimental Brachytherapy Treatment Planning n=15 Participants Single Arm in which eligible patients were women with a diagnosis of 1B2cervical cancer with definitive chemoradiation or radiation therapy who required brachytherapy.
Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position Adaptive Applicator in the Standard Position	0 Participants
Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position Adaptive Applicator in the Shifted Position	15 Participants

Adverse Events

Experimental Brachytherapy Treatment Planning

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Ann Klopp / Associate Professor, Radiation Oncology

UT MD Anderson Cancer Center

Phone: 713-563-6930

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place