Cervical CancerNCT01706705
Magnetic Resonance Imaging (MRI) Brachytherapy Applicator Study
A study testing Intracavitary Applicator Placement, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Intracavitary Applicator Placement, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Oct 2012to 22 Apr 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: 3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator
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.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Intracavitary Applicator Placement, Computed Tomography (CT), Magnetic Resonance Imaging (MRI)
- 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
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracavitary Applicator PlacementDevice
Also called MDA Applicator
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.
Computed Tomography (CT)Other
Also called CT
CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
Magnetic Resonance Imaging (MRI)Other
Also called MRI
MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Brachytherapy Treatment Planning | 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. Receives: Device: Intracavitary Applicator Placement; Other: Computed Tomography (CT); Other: Magnetic Resonance Imaging (MRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the time of implant
Secondary outcomes (1)
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.
Measured: At the time of implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2012 (estimated)
- Study start22 Oct 2012
- Primary completion22 Apr 2018
- Study completion22 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ann Klopp, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01706705
- Sponsor's protocol ID
- 2012-0546
- Other IDs
- NCI-2012-02120
- Status last verified
- Jan 2022
- First submitted
- 11 Oct 2012
- Last updated
- 23 Feb 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Image-guided Intracavitary Brachytherapy Treatment Planning for Cervical Cancer Using a Novel Shielded Applicator
- ClinicalTrials.gov ID
- NCT01706705
- Acronym / sponsor ID
- 2012-0546
- Conditions
- Cervical Cancer
- Keywords
- Cervical Cancer, Radiation therapy, XRT, External beam therapy, Brachytherapy, Intracavitary brachytherapy, ICBT, MRI compatible intracavitary applicators
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 22 Oct 2012 (actual)
- Primary completion
- 22 Apr 2018 (actual)
- Study completion
- 22 Apr 2018 (actual)
- First posted
- 15 Oct 2012 (estimated)
- Results
- Posted 23 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brachytherapy Treatment Planning | Experimental | Device: Intracavitary Applicator Placement, Other: Computed Tomography (CT), Other: Magnetic Resonance Imaging (MRI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1) Women with stage greater than or equal to IB2 cervical cancer treated with definitive chemoradiation or radiation therapy who require intracavitary brachytherapy.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intracavitary Applicator PlacementAlso: MDA ApplicatorMRI-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. | Device | Brachytherapy Treatment Planning |
| Computed Tomography (CT)Also: CTCT scan performed after implant is placed in operating room. CT scan should take about 20 minutes. | Other | Brachytherapy Treatment Planning |
| Magnetic Resonance Imaging (MRI)Also: MRIMRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes. | Other | Brachytherapy Treatment Planning |
Primary outcome
Number of Participants With Improved Image Quality in the Shifted Position
Time frame: 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.
1 secondary outcome
Number of Participants With High Quality Images With the Adaptive Applicator in the Shifted or Standard Position
Time frame: At the time of implant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ann Klopp, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracavitary Applicator Placement, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI) in people with Cervical Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Improved Image Quality in the Shifted Position (time frame: At the time of implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.