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Healthy VolunteerNCT05100927

3D Free-Breathing Multi-echo Acquisition for Whole-body Water/Fat Separation

An observational study of Healthy Volunteer, run by Milton S. Hershey Medical Center.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to help researchers develop MRI imaging techniques that can provide better information for using MRI to treat cancer. MRI is a non-invasive technique that uses magnetic fields and radio waves to create images of the inside of the body. Read more about this study

Who is it for?
Ages 18 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteer
How many people
0 participants
Where
No sites listed yet
Study dates
22 Jan 2022to 1 Jan 2024
Phase
Observational
Are there results?
None posted in the registry

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 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: Healthy volunteers from the local community

Who may be able to join

  • 1. Any male or non pregnant female age ≥18 but ≤ 100 who is capable of giving informed consent.

Who cannot join

  • 1. A subject will be excluded if he/she/they has/have a contraindication to MR scanning based on screening. Examples of contraindications include:
  • Aneurysm clip
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or auto-defibrillator
  • Cochlear implant
  • Ocular foreign body (e.g., metal shavings)
  • Any implanted device (pumps, infusion devices, etc)
  • Shrapnel injuries 2. Subjects will be excluded if it is deemed that he/she/they has/have a condition which would preclude use for technical development (e.g. morbid obesity, claustrophobia, etc.) or present unnecessary risks (e.g. pregnancy, surgery of uncertain type, implant etc.).

About this study

Official title: 3D Free-Breathing Multi-echo Acquisition for Whole-body Water/Fat Separation Utilizing DIXON Method

The purpose of this study is to help researchers develop MRI imaging techniques that can provide better information for using MRI to treat cancer. MRI is a non-invasive technique that uses magnetic fields and radio waves to create images of the inside of the body.

The investigators of this study are developing an MRI imaging technique that will help with treatment planning for cancer patients. Specifically, the method investigating will help to calculate how the dose the patient needs to treat his/her/their cancer is distributed. This information is required for prescribing the dose to the patient for their cancer treatment.

Read the detailed description

Combined magnetic resonance and linear accelerator systems (MR-Linac systems) are a powerful new cancer treatment modality. MR-Linac systems promise improved patient outcomes and decreased side effects compared to conventional radiation therapy (RT) systems. These systems yield exquisite soft tissue imaging, offer imaging during RT delivery, and provide a platform for adaptive RT. However, unlike traditional RT planning with computed tomography (CT) measured in Hounsfield units, the MR signal does not correlate with electron density. Electron density information is required to calculate radiation dose maps for RT planning for adaptive RT.

The MRIdian MR-Linac is a low-field system (0.35 Tesla), which is beneficial for applications in RT because it has less effect on the radiation beam than higher field systems. However, low-field MR systems have imaging challenges compared to high-field MR systems. The resonant frequencies between water and fat at 0.35 Tesla are close and traditional methods of separating these tissues (i.e., DIXON-based methods) are more difficult. Furthermore, spectral-selection of fat is not possible, which means traditional fat saturation methods cannot be used at 0.35T. Currently, neither a fat-saturation sequence nor a multi-echo sequence for fat/water separation is available on the MRIdian MR-Linac system. We propose to implement and test a fat/water separation technique optimized for 0.35T. This sequence will enable sCT generation for MR-only simulation (i.e., RT planning without CT) and adaptive RT.

The original DIXON technique for water/fat separation depends on two signal acquisitions - when the fat and water spins are in-phase and opposed-phase. New DIXON methods are more flexible and enable fat/water separation at echo times that are not directly in- and opposed-phase. At 0.35T, the fat and water spins are slow enough that the first echo (i.e., shortest echo) is a near-in-phase echo. Additional echoes will support a 3-point DIXON reconstruction and B0 mapping for inhomogeneity correction.

The long-term goal of this study is to realize the benefits of MR-guided adaptive RT to decrease toxicity and improve patient outcomes. The specific objective of this study is to develop an MR sequence on the low-field MR-Linac for fat/water separation. For the purposes of Radiation Oncology, multi-echo gradient-echo is a fast method to acquire a 3D stack with a large FOV. The images can be reconstructed using a DIXON-based method to produce multiple image types. The resulting images can be used for sCT, which could greatly assist with auto-contouring methods and adaptive planning on MR-Linac systems. These images are also diagnostically used for functional imaging, specifically Dynamic contrast-enhanced imaging (DCE-MRI), which has shown promise at low field, as well as a non-contrast method magnetic resonance angiography (MRA).

Producing these images requires chemical shift imaging. At low fields, chemical shift imaging is difficult as the spectra of fat and water are very close (52 Hz @ 0.35T as compared to 224 Hz @ 1.5T). Traditional DIXON methods use out-of-phase and in-phase echo times (TEs) to separate fat and water. At 0.35T, these TEs are 9.86ms and 19.7ms, respectively. However, long TEs degrade the signal-to-noise ratio (SNR) and lead to long imaging times, particularly for 3D stacks. In addition, B0 inhomogeneity increases and SNR degrades with longer TEs.

The hypothesis is that at 0.35T, the fat and water spins are slow enough that the first echo (i.e., shortest echo, approximately 1ms) is a near-in-phase echo. Additional echoes will support a 3-point DIXON reconstruction and B0 mapping for inhomogeneity correction. I predict that once this multi-echo gradient echo sequence is implemented on the MRIdian system, it can be used to acquire images that will successfully produce water-only, fat-only, in-phase and opposed-phase images.

Keywords
MRIdian MR-Linac

What participants receive

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

Study groups in NCT05100927
Study groupRoleWhat they receive
An MR pulse sequence developing on the MRIdian systemThis a pilot study to assess and optimize an MR pulse sequence that we are developing on the MRIdian system. It is a single-center trial recruiting only normal volunteers. Volunteers may be grouped by anatomic region of assessment.

What is being measured

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

  1. MR acquisition and reconstruction

    MR methods will be tested in phantoms and then volunteers. Each volunteer will provide images for up to 5 anatomies. When any anatomy has 3 consecutive imaging sessions that meet qualitative metrics for image quality (absence of artifacts), image contrast (proper weighting MR image) and tissue classification (fat/water separation), approval by the Radiation Oncologist will be sought. The project will be complete when all 5 anatomies have obtained approval.

    Measured: 90 minutes

Timeline

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

  1. First posted29 Oct 2021
  2. Study start22 Jan 2022 (estimated)
  3. Primary completion1 Jan 2024 (estimated)
  4. Study completion1 Jan 2024 (estimated)

Why it stopped: PI is leaving the Penn State

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05100927
Sponsor's protocol ID
21-129
Status last verified
Jan 2022
First submitted
6 Oct 2021
Last updated
1 Jun 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteer, run by Milton S. Hershey Medical Center.

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 1 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: withdrawn, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

MR acquisition and reconstruction (time frame: 90 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 1 Jun 2022.

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