GI Organ Tracking Via Balloon Applicators

The Washington University

Status: Withdrawn

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

Treatments: Device: Balloon-tipped catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT05471401

202207133

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Occlusion balloon catheter

Experimental group

Description:

-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.

Treatment:

Device: Balloon-tipped catheter