Inhale and Exhale Breath Holds to Improve the Radiation Therapy Accuracy in People With Upper Abdominal Cancers (INEX-RT P)

University Health Network, Toronto

Status: Not yet enrolling

Conditions: Abdominal Cancer

Treatments: Diagnostic Test: Simulation and treatment imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT07594691

26-5095

Details and patient eligibility

About

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. We hypothesize that we can increase 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).

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Imaging

Experimental group

Treatment:

Diagnostic Test: Simulation and treatment imaging