Your session is about to expire
← Back to Search
Balloon-Tipped Catheter Tracking for Stomach Cancer Radiation Therapy
N/A
Recruiting
Led By Hyun Kim, M.D.
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 18 years of age.
ECOG performance status ≤ 1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up completion of follow-up for all participants (estimated to be 1 year)
Awards & highlights
Study Summary
This trial is testing whether a balloon-tipped catheter placed in the stomach can help track the stomach during radiation therapy, and whether this is a safe method.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include discomfort from the catheter placement, possible irritation of oral/nasal passages, and risk of balloon deflation or misplacement affecting organ tracking accuracy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I am fully active and can carry on all pre-disease activities without restriction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ completion of follow-up for all participants (estimated to be 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~completion of follow-up for all participants (estimated to be 1 year)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging
Secondary outcome measures
Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation
Translation movement of stomach between CBCT scans with and without balloon insufflation
Trial Design
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.
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,936 Previous Clinical Trials
2,299,680 Total Patients Enrolled
Hyun Kim, M.D.Principal InvestigatorWashington University School of Medicine
7 Previous Clinical Trials
231 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had surgery to remove part or all of my esophagus, stomach, or duodenum.I am 18 years old or older.I have had surgery or an injury that changed the structure of my upper airway, esophagus, or stomach.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.
Research Study Groups:
This trial has the following groups:- Group 1: Occlusion balloon catheter
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment open for this research program currently?
"According to the clinicaltrials.gov website, this experiment is not currently enrolling participants and was last updated on October 17th 2022. There are however 2238 other trials recruiting patients at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger