Actively Recruiting
Inhale and Exhale Breath Holds to Improve the Therapeutic Ratio in Upper Abdominal Cancers Treated With SBRT
Led by University Health Network, Toronto · Updated on 2026-05-29
15
Participants Needed
1
Research Sites
35 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new radiation therapy technique called INEX RT that uses both inhale and exhale breath holds during the same course of stereotactic body radiation therapy (SBRT) for patients with abdominal cancer. This approach aims to improve radiation dose delivery to the tumor while reducing exposure to nearby critical organs at risk (OARs). The study plans to treat 15 patients expected to benefit from this method based on the proximity of OARs to the tumor. The goal is to increase the radiation dose to the tumor by at least 10% without increasing the dose to adjacent organs, compared to the current standard of using a single breath hold phase. Participants will have radiation treatments planned using images taken during both inhale and exhale breath holds. For radiation courses with an odd number of treatment sessions, the breath hold phase with better stability or anatomical benefit will be used for the extra session. Patients who may benefit from the combined breath hold technique will receive a treatment plan that splits radiation delivery between inhale and exhale phases. Additional imaging with cone beam CT scans will be done on treatment days to monitor positioning. During the study, patients will undergo radiation therapy with this new technique and have images taken to assess organ movement between breath holds. The main outcome measured is the total radiation dose delivered to both the tumor and critical organs over 12 months. Secondary outcomes include changes in organ position between deep inhale and exhale breath holds. The study involves monitoring radiation delivery accuracy and safety, with follow-up lasting up to a year after treatment.
CONDITIONS
Brief Title
Inhale and Exhale Breath Holds to Improve the Radiation Therapy Accuracy in People With Upper Abdominal Cancers
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Any patient undergoing radiation therapy for a cancer lesion in the abdomen close to organs at risk (OARs) that show movement differences on inhale and exhale breath hold CT scans
- Patients must require at least 3 fractions of radiation therapy
- Critical OARs are within 2 cm of gastrointestinal structures, chest wall, or previous radiation fields
- Able to understand study information and provide written informed consent
You will not qualify if you...
- Inability to perform inhale or exhale breath holds during standard CT simulation evaluation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Radiation therapy duration depending on number of fractions (at least 3 fractions)
Participants undergo radiation therapy using inhale and exhale breath hold imaging to improve accuracy. Additional imaging with cone beam CT is performed on treatment days.
Multiple visits for radiation therapy and imaging on treatment days
Trial Site Locations
Total: 1 location
1
Princess Margaret Cancer Centre Toronto, Ontario
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
Research Team
L
Laura Dawson, MD FRCPSC FASTRO FCAHS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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