GI Organ Tracking Via Balloon Applicators

Not Applicable

Withdrawn

• Conditions: Pancreas Cancer; Rectal Cancer; Esophageal Cancer; Lung Cancer; Intrathoracic--Cancer; Respiratory Organs--Cancer; Stomach Cancer; Kidney Cancer; Larynx Cancer; Digestive Organs--Cancer
• Interventions: Device: Balloon-tipped catheter

• Registration Number: NCT05471401
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-22
• Study Start: 2023-04-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-10
• Last Update Posted: 2024-06-13
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Occlusion balloon catheter	Balloon-tipped catheter	-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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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)