MRI Only Radiation Therapy With CPAP

NCT03397342 | Terminated Results DMC FDA Device

• 1 other identifier: 2017-7745
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Carcinoma Liver; Carcinoma, Pancreatic

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

standard breath hold

NO INTERVENTION

1. Breath-hold CT and 4D-CT without CPAP 2. Breath-hold MRI and 4D-MRI without CPAP a) T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images

CPAP intervention

EXPERIMENTAL

1. Breath-hold CT without CPAP 2. 4D-CT with and without CPAP 3. 4D-MRI with CPAP 1. T1-weighted, T2-weighted, Dixon fat/water, and ultra-short TE images

Device: CPAP machine

Interventions

CPAP machine DEVICE

Use of CPAP machine during MRI

CPAP intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Montefiore Medical Center: collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Madhur Garg
• Organization: Montefiore Medical Center

mgarg@montefiore.org

718-920-4140

Study Officials

• Madhur Garg, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: January 12, 2018
• Study Start: April 24, 2018
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: January 18, 2024
• Results First Posted: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)