An interventional study of Intracavitary Applicator Placement and Computed Tomography (CT) in Cervical Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-02-23.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Other
The goal of this clinical research study is to learn if computed tomography (CT) and magnetic resonance imaging (MRI) images can better help to plan internal radiation treatment.
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.
1,879 studies on the registry are indexed under Uterine Cervical Neoplasms; 565 are open to participants now.
This study's enrollment of 57 is below the median of 100 across 1,375 interventional studies indexed under Uterine Cervical Neoplasms.
Browse Uterine Cervical Neoplasms studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Intracavitary Applicator Placement · Other: Computed Tomography (CT) · Other: Magnetic Resonance Imaging (MRI)
MRI-compatible 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.
Also known as: MDA Applicator
CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
Also known as: CT
MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
Also known as: MRI
Number of Participants With Improved Image Quality in the Shifted Position
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.
Time frame: At the time of implant
Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position
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.
Time frame: At the time of implant
3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer
Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer
Time frame: 24 months from baseline
Magnetic Resonance Imaging (MRI) is Superior to Computed Tomography (CT) Imaging in Delineating a High Risk Target Volume. 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer".
Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.
Time frame: 24 months from baseline ( 2-years)
Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing
MRI-based brachytherapy planning for patients with tumors \>5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI
Time frame: 24 months from baseline ( 2-years)
Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator.
RI-adaptive applicators for treatment planning for every case/patient.
Time frame: 24 months from baseline ( 2-years)
Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques.
Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.
Time frame: Not able to complete
| Milestone | Experimental Brachytherapy Treatment Planning |
|---|---|
| Started | 57 |
| Completed | 37 |
| Not completed | 20 |
| Withdrew: Death | 1 |
| Withdrew: Lack of efficacy | 13 |
| Withdrew: Non-clinical | 6 |
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.
| Participants | Experimental Brachytherapy Treatment Planning |
|---|---|
| Standard Position | 0 |
| Shifted Position | 15 |
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.
| Participants | Single Arm-Study |
|---|---|
| Adaptive Applicator in the Standard Position | 0 |
| Adaptive Applicator in the Shifted Position | 15 |
Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer
No measurements were reported for this outcome.
Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing.
No measurements were reported for this outcome.
MRI-based brachytherapy planning for patients with tumors \>5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI
No measurements were reported for this outcome.
RI-adaptive applicators for treatment planning for every case/patient.
No measurements were reported for this outcome.
Due to lack of a suitable comparison population during this timeframe- at our institution, these protocol-eligible cervical cancer patients were no longer undergoing brachytherapy treatment planning based solely off standard plain films alone.
No measurements were reported for this outcome.
Collected over At the time of implant. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental Brachytherapy Treatment Planning | 1/37 (2.7%) | 0/37 (0%) | 0/37 (0%) |
| Age, Categorical(Participants) | Experimental Brachytherapy Treatment Planning |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 35 |
| >=65 years | 2 |
| Age, Continuous(years) | Experimental Brachytherapy Treatment Planning |
|---|---|
| Median | 40 (25 to 94) |
| Sex: Female, Male(Participants) | Experimental Brachytherapy Treatment Planning |
|---|---|
| Female | 37 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Experimental Brachytherapy Treatment Planning |
|---|---|
| Hispanic or Latino | 10 |
| Not Hispanic or Latino | 27 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Experimental Brachytherapy Treatment Planning |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Experimental Brachytherapy Treatment Planning |
|---|---|
| United States | 37 |
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M.D. Anderson Cancer Center