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Brachytherapy

MRI-Guided Brachytherapy for Gynecologic Cancer

N/A
Waitlist Available
Led By Larissa J Lee, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
ECOG performance status of 2 or less
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 2 years, 5 years
Awards & highlights

Study Summary

This trial is studying MRI tools to improve cancer treatment.

Who is the study for?
This trial is for adults over 18 with gynecologic cancers (like cancer of the endometrium, ovaries, cervix, vagina, or vulva) who are suitable and choose to undergo MRI-guided brachytherapy. They must understand the study and agree to follow its procedures. Prior radiation or chemotherapy is okay. However, those with certain medical implants that aren't safe in an MRI machine or have serious illnesses affecting their ability to participate are excluded.Check my eligibility
What is being tested?
The study aims to improve brachytherapy for gynecologic cancer using new tools developed with magnetic resonance imaging (MRI). Participants will receive this advanced form of treatment which allows precise targeting of cancerous tissue while sparing healthy areas.See study design
What are the potential side effects?
While specific side effects aren't listed for this trial's interventions, typical risks associated with MRI include discomfort from lying still during the scan. Brachytherapy can cause localized pain, swelling, bleeding or bruising at the treatment site; fatigue; skin irritation; and other tissue-specific side effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a confirmed gynecologic cancer and am planning to undergo brachytherapy.
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I can take care of myself but cannot do heavy physical work.
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I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 2 years, 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 2 years, 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Brachytherapy treatment parameters, including V150
Secondary outcome measures
Local-Failure-Free Survival
Overall Survival
Progression Free Survival

Trial Design

2Treatment groups
Experimental Treatment
Group I: MRI Guided BRACHYTHERAPY without TrackerExperimental Treatment2 Interventions
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
Group II: MRI Guided BRACHYTHERAPY with TrackerExperimental Treatment3 Interventions
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MRI
2009
Completed Phase 2
~1370
Brachytherapy
2007
Completed Phase 3
~2100

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalOTHER
1,599 Previous Clinical Trials
11,462,465 Total Patients Enrolled
Dana-Farber Cancer InstituteLead Sponsor
1,072 Previous Clinical Trials
340,357 Total Patients Enrolled
7 Trials studying Gynecologic Cancers
26,054 Patients Enrolled for Gynecologic Cancers
Kaye Foundation, Brigham and Women's HospitalUNKNOWN

Media Library

Brachytherapy (Brachytherapy) Clinical Trial Eligibility Overview. Trial Name: NCT03277469 — N/A
Gynecologic Cancers Research Study Groups: MRI Guided BRACHYTHERAPY with Tracker, MRI Guided BRACHYTHERAPY without Tracker
Gynecologic Cancers Clinical Trial 2023: Brachytherapy Highlights & Side Effects. Trial Name: NCT03277469 — N/A
Brachytherapy (Brachytherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03277469 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there any availability to partake in this clinical trial?

"According to data hosted by clinicaltrials.gov, this medical study is not currently looking for patients as the last update was on October 3rd 2022; however, there a plethora of other trials actively searching for participants."

Answered by AI
~3 spots leftby Sep 2024