MRI-Guided Brachytherapy for Gynecologic Cancer

Recruiting in Palo Alto (17 mi)

Overseen byLarissa J Lee, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Dana-Farber Cancer Institute

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

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.

Inclusion Criteria

I am willing and able to follow the study's requirements, including treatments and visits.

I have a confirmed gynecologic cancer and am planning to undergo brachytherapy.

I can take care of myself but cannot do heavy physical work.

+5 more

Exclusion Criteria

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

I do not have any serious ongoing illnesses that my doctor is still trying to control.

Participant Groups

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.

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

Brachytherapy is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Brachytherapy for: