TerminatedNot Applicable

MRI Only Radiation Therapy With CPAP

Stopped: Study terminated prematurely well short of enrollment target. Only 5 health participants were enrolled

United States5 participantsStarted 2018-04-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: baseline

Reduction of Tumor Motion Using Continuous Positive Airway Pressure

Timeframe: baseline

Trial details

NCT IDNCT03397342

SponsorAlbert Einstein College of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-01

Results submitted2023-12-22

View on ClinicalTrials.gov More Carcinoma Liver trials