Back to results

MRI Only Radiation Therapy With CPAP

Primary Purpose

Carcinoma Liver, Carcinoma, Pancreatic

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CPAP machine

About this trial

This is an interventional supportive care trial for Carcinoma Liver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

standard breath hold

CPAP intervention

Arm Description

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

Breath-hold CT without CPAP 4D-CT with and without CPAP 4D-MRI with CPAP T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images

Outcomes

Primary Outcome Measures

• Assessment of the Internal Target Volume on 4D-MR and 4D-CT

The primary endpoint of aim 1 is that for the 42 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.

• Reduction of Tumor Motion using Continuous Positive Airway Pressure

2. The primary end point of aim 2 is that for the 21 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03397342

First Posted

May 8, 2017

Last Updated

May 3, 2022

Sponsor

Albert Einstein College of Medicine

Collaborators

Montefiore Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT03397342

Brief Title

MRI Only Radiation Therapy With CPAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2022

Overall Recruitment Status

Completed

Study Start Date

April 24, 2018 (Actual)

Primary Completion Date

March 1, 2022 (Actual)

Study Completion Date

March 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Albert Einstein College of Medicine

Collaborators

Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Carcinoma Liver, Carcinoma, Pancreatic

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

5 (Actual)

8. Arms, Groups, and Interventions

Arm Title

standard breath hold

Arm Type

No Intervention

Arm Description

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

Arm Title

CPAP intervention

Arm Type

Experimental

Arm Description

Breath-hold CT without CPAP 4D-CT with and without CPAP 4D-MRI with CPAP T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images

Intervention Type

Device

Intervention Name(s)

CPAP machine

Intervention Description

Use of CPAP machine during MRI

Primary Outcome Measure Information:

Title

• Assessment of the Internal Target Volume on 4D-MR and 4D-CT

Description

Time Frame

baseline

Title

• Reduction of Tumor Motion using Continuous Positive Airway Pressure

Description

Time Frame

baseline

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Madhur Garg, MD

Organizational Affiliation

Montefiore Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montefiore Medical Center

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

MRI Only Radiation Therapy With CPAP

We'll reach out to this number within 24 hrs