Cervical Cancer
Conditions
Keywords
Cervical Cancer, Radiation therapy, XRT, External beam therapy, Brachytherapy, Intracavitary brachytherapy, ICBT, MRI compatible intracavitary applicators, Computed tomography, CT, Magnetic resonance imaging, MRI, MRI compatible applicators, 3D image guided treatment planning, 2D treatment planning
Brief summary
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.
Detailed description
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.
Interventions
DEVICEIntracavitary Applicator Placement
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.
OTHERComputed Tomography (CT)
CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
OTHERMagnetic Resonance Imaging (MRI)
MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1\) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.
Exclusion criteria
1. Patient or tumor anatomy that requires use of a non-MRI-compatible applicator. 2. Patients who require interstitial brachytherapy. 3. Patients whose treating physician feels that they require additional 3D imaging at the time of implant based on physical exam or initial findings. 4. Patients with implantable cardioverter-defibrillator, pacemaker or other implanted device, which precludes MRI acquisition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Improved Image Quality in the Shifted Position | At the time of implant | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position | At the time of implant | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Clinical and Tumor Characteristics of Patients in Whom CT or MRI Can Improve Dosimetric Tumor Coverage and Normal Tissue Sparing | 24 months from baseline ( 2-years) | MRI-based brachytherapy planning for patients with tumors \>5 cm and parametrial invasion on MRI at diagnosis and for those with a high BMI |
| 3D Image-guided Intracavitary Brachytherapy Treatment Planning in Cervical Cancer | 24 months from baseline | Analysis was conducted using JMP Pro statistical software for patients diagnosis of 1B2cervical cancer |
| Relative Resource Utilization for MRI and CT Based Treatment Planning as Compared to Standard Film Based Planning Techniques. | Not able to complete | 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. |
| Feasibility of MRI-based Treatment Planning Utilizing the Shielded MD Anderson Adaptive Applicator. | 24 months from baseline ( 2-years) | RI-adaptive applicators for treatment planning for every case/patient. |
| 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. | 24 months from baseline ( 2-years) | Utility of MRI imaging as compared to CT or MRI can improve dosimetric tumor coverage and normal tissue sparing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 37 |
| Total | 37 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
| Overall Study | Lack of Efficacy | 13 |
| Overall Study | Non-clinical | 6 |
Baseline characteristics
| Characteristic | Experimental Brachytherapy Treatment Planning |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 35 Participants |
| Age, Continuous | 40 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 34 Participants |
| Region of Enrollment United States | 37 participants |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 37 |
| other Total, other adverse events | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Brachytherapy Treatment Planning | Number of Participants With Improved Image Quality in the Shifted Position | Standard Position | 0 Participants |
| Experimental Brachytherapy Treatment Planning | Number of Participants With Improved Image Quality in the Shifted Position | Shifted Position | 15 Participants |
Secondary
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
Population: The adaptive applicator fit into 15 of the evaluated patients so the analysis was limited to these 15 patients.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Brachytherapy Treatment Planning | 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 |
| Experimental Brachytherapy Treatment Planning | 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 |
Other Pre-specified
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
Population: No data collected
Other Pre-specified
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)
Population: No data collected
Other Pre-specified
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)
Population: No data collected
Other Pre-specified
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)
Population: No data collected
Other Pre-specified
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
Population: 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.