Recruiting

INEX RT

Sponsor:

University Health Network, Toronto

Code:

NCT07594691

Conditions

Abdominal Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Simulation and treatment imaging

Study Details

Brief summary:

This is a prospective quality improvement study. The INEX RT P study will prospectively evaluate INEX RT R that optimizes radiation dose delivery to the target while minimizing dose to critical organs at risk (OAR) by treating patients with different phases of breath hold (inhale and exhale) during the same course of SBRT. 15 patients with abdominal cancer whom are expected to achieve a dosimetric advantage from this technique due to OAR proximity to target will be treated using INEX RT. Investigators hypothesize increasing the dose to the RT target by at least 10% while simultaneously decreasing or maintaining dose to adjacent critical OARs when using a combination of breath hold positions to purposefully vary the position of OARs during different fractions of the same treatment course, when compared to RT treatments planned on a single breath hold phase alone (present standard of care).

Conditions

Abdominal Cancer

Study ID

NCT07594691

Start date

May 25, 2026

Status verified date

May, 2026

Completion date

Jan 30, 2028

Anticipated

Primary completion date

May 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Age ≥ 18
  • Any patient undergoing radiation therapy for a cancer lesion in the abdomen in close proximity to OARs that is hypothesized to have differential displacement on inhale and exhale breath hold CT scans of the OAR relative to the tumor.
  • Patients need at least 3 fractions of RT
  • Critical OARs are within 2 cm of luminal GI structures, chest wall, or previous radiation fields
  • Able to receive and understand verbal and written information regarding study and able to give written informed consent

Exclusion Criteria:

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

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Imaging

Interventions

Simulation and treatment imaging

Obtain inhale and exhale breath hold images planned to split radiation delivery between inhale and exhale breath hold phases. For radiotherapy courses with an odd number of fractions, the phase of breath hold with higher reproducibility or anatomic advantage will be used for the additional fraction of radiotherapy. If during the treatment planning the investigators determine that the patients will benefit from the multiple breath holds technique, the patients will be treated using the composite breath hold plan.

Additional one or two cone beam CTs will be obtained on treatment days for all patients using the inhale and exhale breath hold technique.

Primary outcome measure

  • Total dose to radiation targets and OARs [ Time Frame: 12 Months ]

Central Contacts and Locations

Central contacts

Laura Dawson, MD FRCPSC FASTRO FCAHS

416-946-4501Laura.Dawson@uhn.ca

Locations

Princess Margaret Cancer Centre Toronto, Ontario

Recruiting

Toronto, Ontario, Canada, M5G 2M9

Principal Investigator:

Laura Dawson

More Information

Sponsor

University Health Network, Toronto

Last update posted

May 29, 2026

Last verified

May, 2026

Keywords

  • INEX RT
  • SBRT
  • Breath
  • Breath Hold Immobilization

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Health Network, Toronto on 2026-05-29.