Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
No Intervention
standard breath hold
Experimental
CPAP intervention
  • Device: CPAP machine
    Use of CPAP machine during MRI

Recruiting Locations

Montefiore Medical Center
Bronx, New York 10467
Contact:
Alyssa Asaro, BA
718-920-5636
aasaro@montefiore.org

More Details

NCT ID
NCT03397342
Status
Recruiting
Sponsor
Albert Einstein College of Medicine

Study Contact

Alyssa Asaro
(718) 920-5636
aasaro@montefiore.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.