Completed

3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator

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What is being tested

Intracavitary Applicator Placement

+ Computed Tomography (CT)

+ Magnetic Resonance Imaging (MRI)

DeviceOther
Who is being recruted

Urogenital Diseases+10

+ Genital Diseases

+ Uterine Cervical Diseases

Over 18 Years
+5 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Interventional
Study Start: October 2012
See protocol details

Summary

Principal SponsorM.D. Anderson Cancer Center
Last updated: February 23, 2022
Sourced from a government-validated database.Claim as a partner

Study start date: October 22, 2012

Actual date on which the first participant was enrolled.

Treatment planning for patients with cervical cancer treated at MD Anderson is usually performed based on x-ray films taken while the patient is under anesthesia in the operating room. In this study, you will have an MRI and CT scan performed after recovering from anesthesia in addition to the standard x-rays. In order to allow MRI images to be taken, special MRI compatible applicators will be used. The CT and MRI images will be reviewed by the doctor in charge of radiation treatment and will also be used for research purposes. Study Procedures: If you agree to take part in this study, an applicator made of a material that can be used during an MRI will be used. You will have a CT scan and an MRI scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 55 minutes. These scans will be performed after you wake up from general anesthesia. Pain medicine will be given if you feel any discomfort from the placement of the implant. The additional scans will be used to confirm appropriate placement of the applicator and may result in small adjustments to your radiation treatment plan. Length of Study: Your active participation on this study will be complete once you have the CT and MRI scans. Your medical record may be reviewed after the scans for the purposes of the study, but you will not be contacted in the future. This is an investigational study. The applicator that best fits your personal anatomy will be used in this study. A selection of MRI compatible applicators are available. Many of the MRI applicators that will be used are FDA approved. However, in some cases you may have a novel device with a moveable shield placed. This applicator is not FDA approved or commercially available. Up to 57 patients will take part in this study. All will be enrolled at MD Anderson.

NCT01706705
Principal SponsorM.D. Anderson Cancer Center
Last updated: February 23, 2022
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

57 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesUterine Cervical DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsGenital Diseases, FemaleGenital Neoplasms, FemaleNeoplasmsNeoplasms by SiteUrogenital NeoplasmsUterine DiseasesUterine NeoplasmsFemale Urogenital DiseasesUterine Cervical Neoplasms

Criteria

1 inclusion criteria required to participate
1) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy
4 exclusion criteria prevent from participating
Patient or tumor anatomy that requires use of a non-MRI-compatible applicator
Patients who require interstitial brachytherapy
Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings
Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
MRI-compatible intracavitary applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy. Computed tomography (CT) scan and a magnetic resonance imaging (MRI) scan performed after the implant is placed in the operating room. The CT scan should take about 20 minutes and the MRI about 45 minutes.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Texas MD Anderson Cancer Center

Houston, United StatesOpen University of Texas MD Anderson Cancer Center in Google Maps
CompletedOne Study Center