Abdominal CancerINEX-RT PNCT07594691
Inhale and Exhale Breath Holds to Improve the Radiation Therapy Accuracy in People With Upper Abdominal Cancers
A study testing Simulation and treatment imaging in people with Abdominal Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Cancer
- What is being tested?
- Simulation and treatment imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 25 May 2026to 30 Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Inability to perform inhale or exhale breath holds during standard workflow CT simulation evaluation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre Toronto, Ontario
Toronto, Ontario, M5G 2M9
Laura Dawson
About this study
Official title: Inhale and Exhale Breath Holds to Improve the Therapeutic Ratio in Upper Abdominal Cancers Treated With SBRT
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
- Being tested
- Simulation and treatment imaging
- Keywords
- INEX RT, SBRT, Breath, Breath Hold Immobilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation and treatment imagingDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Imaging | Experimental | Not described Receives: Diagnostic Test: Simulation and treatment imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total dose to radiation targets and OARs
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
Measured: 12 Months
Secondary outcomes (1)
Positional change between a deep inhale and deep exhale breath hold
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
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start25 May 2026
- Primary completion30 May 2027 (estimated)
- Study completion30 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594691
- Sponsor's protocol ID
- 26-5095
- Acronym
- INEX-RT P
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhale and Exhale Breath Holds to Improve the Therapeutic Ratio in Upper Abdominal Cancers Treated With SBRT
- ClinicalTrials.gov ID
- NCT07594691
- Acronym / sponsor ID
- INEX-RT P / 26-5095
- Conditions
- Abdominal Cancer
- Keywords
- INEX RT, SBRT, Breath, Breath Hold Immobilization
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 25 May 2026 (actual)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Jan 2028 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Imaging | Experimental | Diagnostic Test: Simulation and treatment imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Inability to perform inhale or exhale breath holds during standard workflow CT simulation evaluation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simulation and treatment imagingObtain 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. | Diagnostic test | Imaging |
Primary outcome
Total dose to radiation targets and OARs
Time frame: 12 Months
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
1 secondary outcome
Positional change between a deep inhale and deep exhale breath hold
Time frame: 12 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
Related trials for Abdominal Cancer
RecruitingPhase 2
Investigation of Ubamatamab Combination Therapy in Adult Participants With Platinum-Resistant Ovarian Cancer
Ovarian Cancer, Fallopian Tube Cancer
Not yet recruiting
Nurse-Led Prehabilitation Before Major Abdominal Cancer Surgery
Colorectal Cancer
RecruitingPhase 1
Study of Preoperative Radiation Therapy in Participants With Resectable Recurrent Abdominal Adrenocortical Carcinoma
Adrenocortical Carcinoma (ACC), Recurrent Adrenocortical Carcinoma (ACC)
RecruitingPhase 1
Individual Response to Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Treatment of Peritoneal Carcinomatosis From Peritoneal Mesothelioma or Atypical Mesothelial Proliferation or From Ovarian, Colorectal, or Appendiceal Histologies
Peritoneal Mesothelioma, Peritoneal Carcinomatosis
RecruitingPhase 3
A Three-Part Phase 3 Study of Sofetabart Mipitecan in Participants With Platinum-Resistant (Part A) and Platinum-Sensitive (Parts B and C) Ovarian Cancer
Ovarian Neoplasms, Fallopian Tube Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation and treatment imaging in people with Abdominal Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Dawson, MD FRCPSC FASTRO FCAHS (416-946-4501 ext. 3276, Laura.Dawson@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total dose to radiation targets and OARs (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.