MRI Only Radiation Therapy With CPAP

MRI-only Radiation Therapy Workflow With Continuous Positive Airway Pressure (CPAP) for Motion Management in the Abdomen

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.

Study Overview

• Status: Terminated
• Conditions: Carcinoma, Pancreatic; Carcinoma Liver
• Intervention / Treatment: Device: CPAP machine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Bronx, New York, United States, 10467
      • Montefiore Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients have liver or pancreas tumors (either primary tumors or metastases) and are scheduled to be treated with radiotherapy (either 3D conformal or intensity-modulation radiotherapy (IMRT) with conventional or hypo- fractionation).
• KPS > 70
• If a biopsy is performed, the patient is at least 1 week post-biopsy.
• The patient's age must exceed 18 years.
• The patients must be able to commit to T1-weighted, T2-weighted, Dixon fat and water, ultrashort-TE, and other clinical or research MR sequence images prior to treatment.
• CPAP Eligibility: CPAP is a safe, effective form of therapy with rare complications. Relative contraindications include patients with bullous lung disease, fibrotic lung disease, Claustrophobia and recurrent sinus or ear infections. The absolute contraindications include obtundation /unconsciousness, chest wall trauma, suspected pneumothorax, persistent nausea/vomiting, active upper GI bleeding, history of recent gastric surgery, facial anomalies/trauma [15,16]. If there is any question about the above history and medical problems, the subject will be referred to a pulmonologist for consultation.
• The patients with above contraindications are not CPAP eligible and are enrolled in Arm 1 for the protocol without CPAP
• The eligible patients are enrolled in Arm 2 for the protocol with CPAP.

Exclusion Criteria:

• Any medical condition, which would make the imaging studies unsafe or poorly tolerated
• Known allergic reaction to contrast or shellfish
• Implanted metal devices or foreign bodies that serve as a contraindication to MR imaging
• Creatinine > 1.4 mg/dl and Creatinine clearance < 20 mg/dl.
• Uncontrolled, clinically significant cardiac arrhythmias
• Severe claustrophobia
• Pregnant female
• KPS <70

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: standard breath hold; Breath-hold CT and 4D-CT without CPAP; Breath-hold MRI and 4D-MRI without CPAP a) T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images
Experimental: CPAP intervention; Breath-hold CT without CPAP; 4D-CT with and without CPAP; 4D-MRI with CPAPT1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images	Device: CPAP machine; Use of CPAP machine during MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the Internal Target Volume on 4D-MR and 4D-CT	The primary endpoint of aim 1 is that for the subjects enrolled in the study there is no statistically significant difference in ITV (internal target volumes) between subjects whose treatment is planned with MRI compared to subjects whose treatment is planned with 4D-CT.	baseline
Reduction of Tumor Motion Using Continuous Positive Airway Pressure	The primary end point of aim 2 is that for the subjects enrolled in Continuous Positive Airway Pressure (CPAP) arm an average tumor motion reduction of at least 12% can be achieved when CPAP is used compared to free breathing.	baseline

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: Montefiore Medical Center
• Investigators: Principal Investigator: Madhur Garg, MD, Montefiore Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2018
• Primary Completion (Actual): March 1, 2022
• Study Completion (Actual): March 1, 2022

Study Registration Dates

• First Submitted: May 8, 2017
• First Submitted That Met QC Criteria: January 10, 2018
• First Posted (Actual): January 12, 2018

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 16, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: 2017-7745

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes