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Low accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Occlusion balloon catheter | Experimental | -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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balloon-tipped catheter | Device | Gastric balloon |
|
| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hyun Kim, M.D. | Washington University School of Medicine | Principal Investigator |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Data will be shared upon review and approval of request by the upper-GI focus group leaders at Siteman Cancer Center.
Contact investigator for details.
Contact investigator for details.
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-Stomach position will be compared between interval scans.
| Day of procedure (Day 1) |
| ID | Term |
|---|---|
| D004938 | Esophageal Neoplasms |
| D007680 | Kidney Neoplasms |
| D007822 | Laryngeal Neoplasms |
| D008113 | Liver Neoplasms |
| D008175 | Lung Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D013274 | Stomach Neoplasms |
| D003110 | Colonic Neoplasms |
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |
| D010039 | Otorhinolaryngologic Neoplasms |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D010038 | Otorhinolaryngologic Diseases |
| D008107 | Liver Diseases |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D013272 | Stomach Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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