GI Organ Tracking Via Balloon Applicators
Study Details
Study Description
Brief Summary
The hypothesis of this study is that a balloon tipped catheter placed in the stomach via an oral or nasogastric route will be safe and permit tracking of the stomach during radiation therapy.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Balloon-tipped catheter -Each participant will have a gastric balloon 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
Gastric balloon
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Outcome Measures
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 [Completion of follow-up for all participants (estimated to be 1 year)]
Secondary Outcome Measures
- 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 [Day of procedure (Day 1)]
-Stomach position will be compared between interval scans.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Scheduled to receive intra-thoracic or abdominal radiation therapy. It is not required that the stomach be in the radiation field.
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At least 18 years of age.
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ECOG performance status ≤ 1
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Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Exclusion Criteria:
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Prior trauma or surgical intervention that would alter the anatomy of the upper airs (nasogastric route), esophagus or stomach.
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Previous complete or partial surgical resection of the esophagus, stomach, or duodenum.
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Presence of implantable devices (e.g., automatic internal cardiac defibrillator, cardiac or gastric pacemaker).
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
Sponsors and Collaborators
- Washington University School of Medicine
Investigators
- Principal Investigator: Hyun Kim, M.D., Washington University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 20-x191