Status:
TERMINATED
MRI Only Radiation Therapy With CPAP
Lead Sponsor:
Albert Einstein College of Medicine
Collaborating Sponsors:
Montefiore Medical Center
Conditions:
Carcinoma Liver
Carcinoma, Pancreatic
Eligibility:
All Genders
18+ years
Phase:
NA
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 Ma...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT03397342
Start Date
April 24 2018
End Date
March 1 2022
Last Update
January 18 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Montefiore Medical Center
The Bronx, New York, United States, 10467