Clinical trialNATerminated
MRI Only Radiation Therapy With CPAP
MRI-only Radiation Therapy Workflow With Continuous Positive Airway Pressure (CPAP) for Motion Management in the Abdomen
- Outcome
- Stopped earlyStudy terminated prematurely well short of enrollment target. Only 5 health participants were enrolled (Enrollment)
- Phase
- NA
- Status
- Terminated
- Study type
- Interventional
- Start
- 24 April 2018
- Expected end
- 1 March 2022
- Enrollment
- 5 participants
- Sites
- 1
- Primary outcomes
- Assessment of the Internal Target Volume on 4D-MR and 4D-CT; Reduction of Tumor Motion Using Continuous Positive Airway Pressure
- Sponsor
- Other
- Results posted
- 2024-01-18
- Last update
- 18 January 2024
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Brief summary public domain (ClinicalTrials.gov)
The goal of this imaging study is to evaluate and improve the treatment planning techniques for abdominal radiation therapy. To accurately treat a tumor with radiation, Computed Tomography (CT) and Magnetic Resonance Images (MRI) are used to distinguish a tumor from normal, healthy tissue. However the quality of these images can be distorted by motion from breathing. To decrease motion, a patient may be asked to hold their breath or compress the abdomen, but currently there is no standard or best management option for all patients. This study will explore the use continuous positive airway pressure (CPAP), a pressurized breathing mask, during MRI or CT imaging to decrease motion in the abdomen and produce higher quality images. With these additional images, we will also explore the feasibility of creating treatment plans using the CPAP MRI images alone.
Detailed description public domain (ClinicalTrials.gov)
Patients will undergo both CT and MRI prior to abdominal radiation therapy and CBCT and orthogonal kV/MV images prior to each treatment delivery. A two arm study will be performed and patients will be enrolled into a given arm according to their eligibility. Arm 1 is for patients that are either not eligible for CPAP or that are unable to tolerate CPAP. These patients will undergo breath-hold and 4D imaging for both CT and MRI without CPAP. Arm 2 is for patients that are eligible for CPAP and able to tolerate CPAP. These patients will undergo breath-hold CT without CPAP, 4D-CT with and without CPAP and 4D-MRI with CPAP. Two specific aims will be investigated. In Aim 1, we will explore the feasibility of using a MRI-only in Radiation Oncology workflow. A probabilistic classification method will be utilized to generate a pseudo-CT from MRI to support treatment planning and image guidance for radiation therapy. The quality of the pseudo-CT will be evaluated by comparing it with CT. In addition, the reverse mapping will be investigated to create pseudo-MRI from CBCT to improve visualization of treatment targets and soft tissue prior to treatment delivery. In Aim 2, we will evaluate the utility of CPAP as a novel motion reduction methodology for patients with liver and pancreas cancer, to this end CT images with and without CPAP will be used. The evaluation will be based on the changes of motion magnitude, the achievable volumetric reduction in treatment target volumes, and doses to the targets and critical organs.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Assessment of the Internal Target Volume on 4D-MR and 4D-CT [baseline].
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Reduction of Tumor Motion Using Continuous Positive Airway Pressure [baseline].