Balloon-Tipped Catheter Tracking for Stomach Cancer Radiation Therapy

Recruiting in Palo Alto (17 mi)

Overseen byHyun Kim, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Trial Summary

What is the purpose of this trial?The hypothesis of this study is that an occlusion balloon catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.

Eligibility Criteria

This trial is for adults at least 18 years old who are scheduled to receive radiation therapy in the chest or abdomen area. They must be relatively healthy (ECOG ≤ 1) and able to consent. It's not suitable for those with altered upper airway anatomy, prior stomach surgeries, or implantable devices like pacemakers.

Inclusion Criteria

I am 18 years old or older.

I am scheduled for radiation therapy in my chest or abdomen.

I am fully active and can carry on all pre-disease activities without restriction.

+1 more

Exclusion Criteria

I have had surgery to remove part or all of my esophagus, stomach, or duodenum.

I have had surgery or an injury that changed the structure of my upper airway, esophagus, or stomach.

Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).

Participant Groups

The study tests if a balloon-tipped catheter can safely track the stomach's position during radiation therapy for various cancers. The device is placed through the mouth or nose into the stomach before treatment.

1Treatment groups

Experimental Treatment

Group I: Occlusion balloon catheterExperimental Treatment1 Intervention

-Each participant will have an embolectomy balloon that is FDA approved for peripheral and neurovasculature temporary occlusion placed by nose or mouth. Anatomical position of balloon will be verified by on-board MR or CT imaging in to assess feasibility of using a duodenal balloon in this population. Participants who are imaged on the MR treatment machine will also be imaged with 4 or 8 frame per second sagittal imaging to assess real-time stomach and balloon respiratory motion. Participants imaged on CT based imaging (i.e. Ethos/Halcyon ring gantry system) will have CBCTs acquired at timed intervals (approximately 5-10 minutes between scans). After imaging, the balloon will be deflated and removed at that time.