Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07594691

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Inability to perform inhale or exhale breath holds during standard CT simulation evaluation

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

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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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