Cervical CancerNCT02993900
Image-Guided Gynecologic Brachytherapy
A study testing Image-Guided Brachytherapy in people with Cervical Cancer and Uterine Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial summary
This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Cervical Cancer, Uterine Cancer, Vaginal Cancer
- What is being tested?
- Image-Guided Brachytherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2016to Dec 2028
- 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 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the SKCCC at Johns Hopkins.
- Site/Stage
- Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
- Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
- Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
- Carcinoma of the vagina: Stage I-IVA or vaginal recurrence
Show all 14Show fewer
- Carcinoma of the vulva: Stage I-IVA or recurrence
- Carcinoma of the urethra based on treating physician's discretion
- Patients who have received prior radiation or chemotherapy may be enrolled on this study.
- Age > 18 years. Children do not develop these malignancies and therefore are not considered candidates for this trial.
- Life expectancy of greater than 6 months.
- ECOG performance status of <2 or greater, based on treating physician's discretion
- MRI of the pelvis or PET-CT within 4 months before registration
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Absolute neutrophil count < 500 at the time of enrollment
- A history of metal in the head or eyes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The SKCCC at Johns Hopkins
Baltimore, Maryland, 21287
Shirl DiPasquale, R.N., 410-614-1598, sdipasq1@jhmi.edu
About this study
Official title: A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose of this study is to investigate the ability of MRI to successfully guide the placement of the brachytherapy applicator necessary to treat participants' gynecologic cancer. The Investigators want to see if the use of MRI will do a better job of assessing the tumor at the time of brachytherapy than the routinely used CT scan. The Investigators also want to determine if the use of MRI will enable doctors to reduce the radiation dose received by the body during the process of treating the tumor.
Read the detailed description
The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases will have lower OAR doses than standard CT-based cases due to more conformal planning. The Investigators will determine dose thresholds for radiation-related toxicity after treatment. The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment, thereby enabling improved recommendations on dose limits to the OAR.
- Conditions
- Cervical Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Bladder Cancer
- Being tested
- Image-Guided Brachytherapy
- Medical subject headings
- Uterine Cervical Neoplasms, Uterine Neoplasms, Vaginal Neoplasms, Vulvar Neoplasms, Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Image-Guided BrachytherapyDevice
Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans
| Study group | Role | What they receive |
|---|---|---|
| Image-Guided Brachytherapy | Experimental | Magnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy Receives: Device: Image-Guided Brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosing changes
To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review.
Measured: 3 years
Secondary outcomes (3)
The rate of treatment-related toxicity
To determine the rate of treatment-related toxicity within 3 months, 6 months and 1 year after MR Simulator Suite-guided placement.
Measured: 3 months, 6 months and 1 year
Time to local failure
To determine the local failure rates at 1 year and 2 year after MR Simulator Suite-guided placement.
Measured: 1 year and 2 year
Rate of survival
To determine the overall survival rates at 1 year and 2 year after MR Simulator Suite-guided placement.
Measured: 1 year and 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2016 (estimated)
- Study start15 Dec 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Akila Viswanathan, M.D., Principal investigator, Johns Hopkins Department of Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02993900
- Sponsor's protocol ID
- J1660
- Other IDs
- IRB00098525, R21CA167800
- Status last verified
- Dec 2025
- First submitted
- 30 Nov 2016
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial To Evaluate Image-Guided Gynecologic Brachytherapy In The MR Simulator Suite
- ClinicalTrials.gov ID
- NCT02993900
- Acronym / sponsor ID
- J1660
- Conditions
- Cervical Cancer, Uterine Cancer, Vaginal Cancer, Vulvar Cancer, Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Dec 2016 (estimated)
- 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.
This research is being done to evaluate multimodality imaging, including magnetic resonance imaging-guided therapy (MRT), as a possible treatment for gynecologic cancers. The therapy takes place in the Department of Radiation Oncology at the Johns Hopkins SKCCC. The purpose of this study is to investigate the ability of MRI to successfully guide the placement of the brachytherapy applicator necessary to treat participants' gynecologic cancer. The Investigators want to see if the use of MRI will do a better job of assessing the tumor at the time of brachytherapy than the routinely used CT scan. The Investigators also want to determine if the use of MRI will enable doctors to reduce the radiation dose received by the body during the process of treating the tumor.
Detailed description
The goal of this trial is to assess how magnetic resonance imaging (MRI) may be used to improve tumor and normal tissue volume delineation, reducing toxicity and recurrence in gynecologic brachytherapy. The Investigators will compare dosimetric values to the organs at risk (OAR) with CT versus MRI planning. The Investigators anticipate that MR-planned cases will have lower OAR doses than standard CT-based cases due to more conformal planning. The Investigators will determine dose thresholds for radiation-related toxicity after treatment. The Investigators will compare toxicity rates at 6 months, 1 and 2 years after treatment, thereby enabling improved recommendations on dose limits to the OAR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Image-Guided Brachytherapy | Experimental | Device: Image-Guided BrachytherapyMagnetic Resonance Imaging (MRI) guided brachytherapy Procedure: Image-Guided Brachytherapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants must have histologically or cytologically confirmed carcinoma. Central pathology review is not required; however, pathology will be reviewed at the SKCCC at Johns Hopkins.
- Site/Stage
- Any patient eligible for internal implantation without MR guidance will be considered eligible for this protocol. Standard criteria for internal implantation include:
- Carcinoma of the cervix: Stage I-IVA or vaginal recurrence
- Carcinoma of the uterus: Stage IIIB (vaginal involvement), inoperable, or vaginal recurrence
Key exclusion criteria (3 listed)
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Absolute neutrophil count < 500 at the time of enrollment
- A history of metal in the head or eyes
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 |
|---|---|---|
| Image-Guided BrachytherapyBrachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans | Device | Image-Guided Brachytherapy |
Primary outcome
Dosing changes
Time frame: 3 years
To quantify the relative reduction of dose to rectum, sigmoid and bladder obtained after MR Simulator Suite-guided placement, as compared to standard CT guided treatment based on historical information and literature review.
3 secondary outcomes
The rate of treatment-related toxicity
Time frame: 3 months, 6 months and 1 year
Time to local failure
Time frame: 1 year and 2 year
Rate of survival
Time frame: 1 year and 2 year
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 18 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Cervical Cancer
RecruitingPhase 2
Adebrelimab ±Induction Chemotherapy Followed by Concurrent Chemoradiotherapy for Unresectable Locally Advanced ESCC
Esophageal Squamous Cell Carcinoma, Immunotherapy
Recruiting
Feasibility of the "One-Finger Technique" for Identifying the Upper Left Ureter During Para-Aortic Lymphadenectomy
Ovary Cancer, Cervical Cancer
Active, not recruitingObservational study
Predictive Biomarkers for Precision Management of Pre-cancerous Cervical Neoplasia
HSIL, High Grade Squamous Intraepithelial Lesion, DNA Methylation
Active, not recruiting
Addressing Stigma in Screening and Diagnostic Delay for Cervical Cancer
Cervical Cancer Screening
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
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.
Akila Viswanathan, M.D. principal investigator
Johns Hopkins Department of Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Image-Guided Brachytherapy in people with Cervical Cancer and Uterine Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins 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 14 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 18 Dec 2025. 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?
Contact Shirley DiPasquale, R.N. (410-614-1598, sdipasq1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dosing changes (time frame: 3 years). 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 18 Dec 2025.