Carcinoma LiverNCT03397342

MRI Only Radiation Therapy With CPAP

A study testing CPAP machine in people with Carcinoma Liver and Carcinoma, Pancreatic, run by Albert Einstein College of Medicine at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Carcinoma Liver, Carcinoma, Pancreatic
What is being tested?: CPAP machine
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUnited States
Study dates: 24 Apr 2018to 1 Mar 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Montefiore Medical Center
The Bronx, New York, 10467

Other trials in United States

About this study

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

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.

Read the 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.

Conditions: Carcinoma Liver, Carcinoma, Pancreatic
Being tested: CPAP machine
Medical subject headings: Carcinoma, Hepatocellular, Pancreatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPAP machineDevice
Use of CPAP machine during MRI

Study groups in NCT03397342
Study group	Role	What they receive
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 Receives: Device: CPAP machine

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Apr 20181 Mar 2022

First posted12 Jan 2018
Study start24 Apr 2018
Primary completion1 Mar 2022
Study completion1 Mar 2022

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

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Carcinoma LiverStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03397342
Sponsor's protocol ID: 2017-7745
Status last verified: Jan 2024
First submitted: 8 May 2017
Last updated: 18 Jan 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: MRI-only Radiation Therapy Workflow With Continuous Positive Airway Pressure (CPAP) for Motion Management in the Abdomen
ClinicalTrials.gov ID: NCT03397342
Acronym / sponsor ID: 2017-7745
Conditions: Carcinoma Liver, Carcinoma, Pancreatic
Study type: Interventional
Recruitment status: TerminatedReason stopped: Study terminated prematurely well short of enrollment target. Only 5 health participants were enrolled
Enrolment: 5 participants (actual)
Lead sponsor: Albert Einstein College of MedicineUniversity, hospital or other
Collaborators: Montefiore Medical Center
Study start: 24 Apr 2018 (actual)
Primary completion: 1 Mar 2022 (actual)
Study completion: 1 Mar 2022 (actual)
First posted: 12 Jan 2018 (actual)
Results: Posted 18 Jan 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
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	Device: CPAP machine1. 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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CPAP machineUse of CPAP machine during MRI	Device	CPAP intervention

Primary outcome

Assessment of the Internal Target Volume on 4D-MR and 4D-CT
Time frame: baseline
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.
Reduction of Tumor Motion Using Continuous Positive Airway Pressure
Time frame: baseline
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.

Results and safety

Results posted to the registry on 18 Jan 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Standard Breath Hold (4D-MRI Without CPAP)	5	5
CPAP Intervention (4D-MRI With CPAP)	0	0

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

Time frame: baseline

Population analysed: Internal target volume (ITV) assessments were not conducted as only healthy volunteers were enrolled into the study. There is no data to report.

Primary outcome: Reduction of Tumor Motion Using Continuous Positive Airway Pressure

Time frame: baseline

Population analysed: No participants were enrolled into the arm/group entailing 4D-MRI with CPAP and, as such, there is no tumor motion data to evaluate.

Adverse events

Time frame: Adverse events were collected initiation of MRI scan to discharge from facility, up to 4 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Standard Breath Hold (4D-MRI Without CPAP)	0 of 5 (0%)	0 of 5 (0%)	0 of 5
CPAP Intervention (4D-MRI With CPAP)	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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A Study of VRT106, Combined With Camrelizumab, and Apatinib for Advanced HCC
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Not yet recruitingObservational study
A Post Approval Study to Evaluate Safety and Effectiveness of Multicompartmental Dosimetry Planning.
Hepatocellular Carcinoma (HCC)
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruitingPhase 2
TheraSphere With Durvalumab and Tremelimumab for HCC
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Madhur Garg, MD principal investigator

Montefiore Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CPAP machine in people with Carcinoma Liver and Carcinoma, Pancreatic, run by Albert Einstein College of Medicine at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assessment of the Internal Target Volume on 4D-MR and 4D-CT (time frame: baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03397342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jan 2024.