Gynecologic CancerNCT03277469
Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
A study testing MRI, Brachytherapy and MRI Tracker in people with Gynecologic Cancer, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer
- What is being tested?
- MRI, Brachytherapy and MRI Tracker
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2017to 15 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment. Eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin.
- Age of 18 years or older are eligible.
- ECOG performance status of 2 or less.
- Patients who have received prior radiation or chemotherapy may be enrolled on this study.
- Participant is deemed to be an appropriate candidate for MRI-guided brachytherapy by the radiation oncologist and the patient elects to be treated with MRI-guided brachytherapy.
- Participant provides informed consent for prospective collection of relevant medical records for analysis of clinical outcome and treatment-planning techniques.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic ulcer disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirements.
- Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.
Read the detailed description
This research study is designed to develop new technology using MR imaging to improve the brachytherapy procedure for participants with gynecologic cancer. The brachytherapy procedure will take place in an MRI procedure room within the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. The purpose of the study will be to evaluate whether the use of an MR-tracking device will improve the placement of the brachytherapy catheters. This information will also be used to develop new software for real-time brachytherapy planning by our physics team. The investigators believe that the development of an MR-tracking device will allow them to better place the brachytherapy catheters for radiation treatment and ultimately improve outcomes for patients, including better local tumor control and a lower risk of side effects. The investigators will also evaluate new MRI protocols to better define the tumor at the time of brachytherapy. The brachytherapy treatment planning and delivery will follow standard of care.
In the past, brachytherapy treatment planning and delivery for gynecologic cancer was based on plain-film X-rays, which did not account for the shape of the tumor, the unique anatomy of an individual patient or the response to pelvic radiation therapy. In the last decade, advances in technology have made it possible to perform the brachytherapy procedure and to plan the delivered radiation dose based on CT or MR imaging. The use of CT or MR imaging for brachytherapy planning is increasingly common in the United States, and has been shown to result in improved tumor controls rates and a lower risk of radiation complications. The use of MRI-guidance during the brachytherapy procedure is unique and this study will contribute the advancement of this important technology. About half of the participants in this study will be selected to have the MRI-guided brachytherapy procedure with the use of an MRI-tracking device. This device will provide real-time positioning information of the individual brachytherapy catheters while they are being placed and adjusted within the tumor. The MR-tracker will also be used to develop new software that will allow our physics team to generate a near-instantaneous brachytherapy plan as individual catheters are placed during the procedure. The investigators hope that these advances in technology will have a meaningful impact on further increasing tumor control and limiting the complication risk for our participants.
- Conditions
- Gynecologic Cancer
- Being tested
- MRI, Brachytherapy, MRI Tracker
- Keywords
- Gynecologic Cancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
BrachytherapyRadiation
Radiation therapy that is delivered by inserting radioactive sources directly into a tumor
MRI TrackerDevice
The MR tracking device consists of a series of radiofrequency (RF) microcoils that are embedded into brachytherapy catheter stylet. The RF microcoils allows for accurate spatial localization of an individual brachytherapy catheter.
| Study group | Role | What they receive |
|---|---|---|
| MRI Guided BRACHYTHERAPY with Tracker | Experimental | * Standard pelvic MRI sequences will be obtained
* MRI Tracker is used during catheter positioning with serial MR imaging during implant
* All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice
* The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source Receives: Device: MRI; Radiation: Brachytherapy; Device: MRI Tracker |
| MRI Guided BRACHYTHERAPY without Tracker | Experimental | * Standard pelvic MRI sequences will be obtained
* Standard process is used with serial MR imaging to evaluate catheter position during implant
* All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice
* The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source Receives: Device: MRI; Radiation: Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brachytherapy treatment parameters, including V150
Comparison of brachytherapy treatment parameters for patients treated with or without use of an MR-tracker. V150 is the tumor volume that receives at least 150% of the prescribed radiation dose and is a measure of radiation dose heterogeneity
Measured: 3 weeks
Secondary outcomes (3)
Local-Failure-Free Survival
Time from diagnosis or recurrence to time of local failure
Measured: Baseline to 2 years, 5 years
Progression Free Survival
Time from diagnosis or recurrence to time of documented progression or death
Measured: Baseline to 2 years, 5 years
Overall Survival
Time from diagnosis or recurrence to time of death
Measured: Baseline to 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2017
- Study start13 Nov 2017
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Responsible party
- Principal investigator, Martin T. King, MD, PhD, Brigham and Women's Hospital
- Investigators
- Martin King, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03277469
- Sponsor's protocol ID
- 17-128
- Status last verified
- Mar 2026
- First submitted
- 7 Sep 2017
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Brachytherapy Application and Delivery With MRI Guidance for Gynecologic Cancer
- ClinicalTrials.gov ID
- NCT03277469
- Acronym / sponsor ID
- 17-128
- Conditions
- Gynecologic Cancer
- Keywords
- Gynecologic Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Dana-Farber Cancer Institute
- Study start
- 13 Nov 2017 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Sep 2027 (estimated)
- First posted
- 11 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to develop new tools using magnetic resonance imaging (MRI) that will improve the brachytherapy procedure and treatment for participants with gynecologic cancer.
Detailed description
This research study is designed to develop new technology using MR imaging to improve the brachytherapy procedure for participants with gynecologic cancer. The brachytherapy procedure will take place in an MRI procedure room within the Advanced Multimodality Image-Guided Operating (AMIGO) suite at Brigham and Women's Hospital. The purpose of the study will be to evaluate whether the use of an MR-tracking device will improve the placement of the brachytherapy catheters. This information will also be used to develop new software for real-time brachytherapy planning by our physics team. The investigators believe that the development of an MR-tracking device will allow them to better place the brachytherapy catheters for radiation treatment and ultimately improve outcomes for patients, including better local tumor control and a lower risk of side effects. The investigators will also evaluate new MRI protocols to better define the tumor at the time of brachytherapy. The brachytherapy treatment planning and delivery will follow standard of care.
In the past, brachytherapy treatment planning and delivery for gynecologic cancer was based on plain-film X-rays, which did not account for the shape of the tumor, the unique anatomy of an individual patient or the response to pelvic radiation therapy. In the last decade, advances in technology have made it possible to perform the brachytherapy procedure and to plan the delivered radiation dose based on CT or MR imaging. The use of CT or MR imaging for brachytherapy planning is increasingly common in the United States, and has been shown to result in improved tumor controls rates and a lower risk of radiation complications. The use of MRI-guidance during the brachytherapy procedure is unique and this study will contribute the advancement of this important technology. About half of the participants in this study will be selected to have the MRI-guided brachytherapy procedure with the use of an MRI-tracking device. This device will provide real-time positioning information of the individual brachytherapy catheters while they are being placed and adjusted within the tumor. The MR-tracker will also be used to develop new software that will allow our physics team to generate a near-instantaneous brachytherapy plan as individual catheters are placed during the procedure. The investigators hope that these advances in technology will have a meaningful impact on further increasing tumor control and limiting the complication risk for our participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MRI Guided BRACHYTHERAPY with Tracker | Experimental | Device: MRI, Radiation: Brachytherapy, Device: MRI Tracker* Standard pelvic MRI sequences will be obtained * MRI Tracker is used during catheter positioning with serial MR imaging during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source |
| MRI Guided BRACHYTHERAPY without Tracker | Experimental | Device: MRI, Radiation: Brachytherapy* Standard pelvic MRI sequences will be obtained * Standard process is used with serial MR imaging to evaluate catheter position during implant * All patients will undergo 3D-based image acquisition for brachytherapy treatment planning per standard clinical practice * The brachytherapy modality to be used is high-dose-rate brachytherapy using an iridum-192 stepping source |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Ability to understand and the willingness to sign a written informed consent document. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
- Participants must have a biopsy-proven diagnosis of primary or recurrent gynecologic cancer for which intracavitary or interstitial brachytherapy is planned as standard treatment. Eligible disease sites include primary or recurrent cancer of endometrial, ovarian, cervical, vaginal, or vulvar origin.
- Age of 18 years or older are eligible.
- ECOG performance status of 2 or less.
- Patients who have received prior radiation or chemotherapy may be enrolled on this study.
Key exclusion criteria (2 listed)
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, interstitial lung disease, active peptic ulcer disease or gastritis, active bleeding diatheses, serious chronic gastrointestinal conditions associated with diarrhea or psychiatric illness/social situations that would limit compliance with study requirements.
- Contraindication to MRI identified by the MR procedure screening form, such as a pacemaker, aneurysm clip, inner ear implant, neurostimulator, or other non-MR compatible implant or device.
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 |
|---|---|---|
| MRIMedical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body | Device | MRI Guided BRACHYTHERAPY with Tracker, MRI Guided BRACHYTHERAPY without Tracker |
| BrachytherapyRadiation therapy that is delivered by inserting radioactive sources directly into a tumor | Radiation | MRI Guided BRACHYTHERAPY with Tracker, MRI Guided BRACHYTHERAPY without Tracker |
| MRI TrackerThe MR tracking device consists of a series of radiofrequency (RF) microcoils that are embedded into brachytherapy catheter stylet. The RF microcoils allows for accurate spatial localization of an individual brachytherapy catheter. | Device | MRI Guided BRACHYTHERAPY with Tracker |
Primary outcome
Brachytherapy treatment parameters, including V150
Time frame: 3 weeks
Comparison of brachytherapy treatment parameters for patients treated with or without use of an MR-tracker. V150 is the tumor volume that receives at least 150% of the prescribed radiation dose and is a measure of radiation dose heterogeneity
3 secondary outcomes
Local-Failure-Free Survival
Time frame: Baseline to 2 years, 5 years
Progression Free Survival
Time frame: Baseline to 2 years, 5 years
Overall Survival
Time frame: Baseline to 2 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Martin King, MD, PhD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI, Brachytherapy and MRI Tracker in people with Gynecologic Cancer, run by Brigham and Women's Hospital 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 7 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Brachytherapy treatment parameters, including V150 (time frame: 3 weeks). 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 22 Apr 2026.