Clinical trial · Interventional
Inhale and Exhale Breath Holds to Improve the Radiation Therapy Accuracy in People With Upper Abdominal Cancers
Inhale and Exhale Breath Holds to Improve the Therapeutic Ratio in Upper Abdominal Cancers Treated With SBRT
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Abdominal Cancer | Malignant Abdominal Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Simulation and treatment imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Imaging
- interventionNames
- Diagnostic Test: Simulation and treatment imaging
Primary outcomes (1)
- measure
- Total dose to radiation targets and OARs
- timeFrame
- 12 Months
- description
- Total dose to radiation targets and OARs on standard workflow (FB ITV or exhale/inhale single breath hold phase only) compared to INEX RT. Unit: Gy
Secondary outcomes (1)
- measure
- Positional change between a deep inhale and deep exhale breath hold
- timeFrame
- 12 Months
- description
- Evaluate the motion of critical OARs during inhale and exhale breath holding techniques during simulation and during daily treatments, including the magnitude of positional change between a deep inhale and deep exhale breath hold. Unit: mm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
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