GI Organ Tracking Via Balloon Applicators

Study Overview
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Brief Summary
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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.

Official Title
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GI Organ Tracking Via Balloon Applicators

Conditions
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Esophageal Cancer, Kidney Cancer, Larynx Cancer, Liver Cancer, Lung Cancer, Digestive Organs--Cancer, Intrathoracic--Cancer, Respiratory Organs--Cancer, Pancreas Cancer, Small Intestine Cancer, Stomach Cancer, Colon Cancer, Rectal Cancer

Intervention / Treatment
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* Device: Balloon-tipped catheter


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to receive intra-thoracic or abdominal radiation therapy. It is not required that the stomach be in the radiation field. At least 18 years of age. ECOG performance status ≤ 1 Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable). Exclusion Criteria: Prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach. Previous complete or partial surgical resection of the esophagus, stomach, or duodenum. Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Occlusion balloon catheter<br>-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. | Device: Balloon-tipped catheter<br>* Gastric balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants who undergo successful inflation of the gastric balloon with oral contrast agent, with verification by MR or CT imaging |  | Completion of follow-up for all participants (estimated to be 1 year) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of grade grade ≥ 2 adverse events that are probably or definitely associated with the balloon inflation |  | Completion of follow-up (estimated to be 4 weeks) | 
| Translation movement of stomach between CBCT scans with and without balloon insufflation | -Stomach position will be compared between interval scans. | Day of procedure (Day 1) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastric balloon