4D-MRI for Precision Medicine

NCT04657042 | Recruiting

• 1 other identifier: HSR20040
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to develop new ways to make medical images of the lungs and liver of adults using a technique called four-dimensional magnetic resonance imaging (4D-MRI). This technique produces three-dimensional movies of the inside of the chest and abdomen while the patient is breathing. (The fourth dimension is time!) This new way of medical imaging is being developed to help cancer patients undergoing radiation therapy. Radiation therapy is used to treat cancerous tumors. For radiation therapy to be effective, the precise size, shape, and location of the tumor within the body must be known. A particular difficulty for radiation treatment of lung and liver cancer is that the tumor moves during treatment because the patient is breathing. Therefore, tumor motion must also be incorporated into the treatment plan. This study aims to improve radiation treatment planning through better targeting and dose estimation based on 4D-MRI. Before this new imaging method can be used for radiation treatment planning, it must be tested in living, breathing volunteers.

Conditions

Healthy Volunteers; Liver Cancer; Lung Cancer

Outcome Measures

Primary Outcomes (3)

• Image quality metrics in healthy volunteers

  General 4D-MRI image quality will be assessed based on signal-to-noise ratio, number of distinct images per breathing cycle, total necessary imaging time, and image quality index.

  single imaging session, lasting up to 2 hours

• Image quality metrics in cancer patients

  We hypothesize that our ultra-quality 4D-MRI methodology will outperform 4D-CT for motion management of radiotherapy in the lungs and the liver. We will test this hypothesis by comparing image quality based on tumor volume consistency, number of trackable landmarks, motion measurement accuracy, and image quality index.

  single imaging session, lasting up to 2 hours

• DVF errors in healthy volunteers and cancer patients

  We hypothesize that our motion modeling method based on 4D-MRI will outperform current DIR algorithms for respiratory motion estimation. We will test this hypothesis by comparing our method to five existing DIR algorithms, based on the magnitude error (Em) and the angular error (Ea) of the calculated deformation vector field (DVF).

  single imaging session, lasting up to 2 hours

Study Arms (3)

Healthy

Healthy volunteers from the local community

Diagnostic Test: Magnetic Resonance Imaging

Liver cancer

Patients undergoing radiotherapy for liver cancer

Diagnostic Test: Magnetic Resonance Imaging

Lung cancer

Patients undergoing radiotherapy for lung cancer

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Four-dimensional MRI of torso

Healthy; Liver cancer; Lung cancer

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 30 lung cancer patients, 30 liver cancer patients, and 40 healthy human volunteers will receive MRI examinations at the University of Virginia to directly measure respiratory motion in the thorax and abdomen. All subject populations will include roughly equal male and female representations. The subject populations will have minority and ethnic representation typical of the local population area that includes the University of Virginia. No specific racial or ethnic group will be excluded. All subjects must have the ability to understand the requirements of the study and must provide informed consent with a personal signature. No persons from vulnerable populations will be included in this study.

You may qualify if:

• Patient is 21 or older
• Patient has primary or metastatic tumor(s) in the lungs or the liver
• Diameter of the tumor(s) is less than 7 cm
• Patient will receive radiation therapy (ordered by the treating Radiation Oncologist) as part of their treatment regimen
• Patient will undergo a planning CT scan with tumor motion assessment (planning 4D-CT ordered by the treating Radiation Oncologist) as part of their treatment regimen
• Patient has signed informed consent and is willing to comply with the 4D-MRI imaging protocol
• Subject is 18 or older
• Subject has signed informed consent and is willing to comply with the 4D-MRI imaging protocol

You may not qualify if:

• Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel, etc.
• Subjects who have difficulty lying flat on their back for extended periods of time
• Patients with any serious/poorly controlled medical or psychological conditions that would complicate protocol compliance
• Too large to adequately fit in the magnet bore or RF coils
• Claustrophobia
• Females who are pregnant or lactating
• Presence of active or chronic infection

Sponsors & Collaborators

• University of Virginia: lead
• Duke University: collaborator
• The Hong Kong Polytechnic University: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Lung Neoplasms

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• G. Wilson Miller, PhD

  Univsersity of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Roselove N Nunoo-Asare, MA

CONTACT

4342436074; RNN3B@VIRGINIA.EDU

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology and Medical Imaging

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 8, 2020
• Study Start: November 5, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: Starting in approximately 2023, with no anticipated end date
• Access Criteria: undecided

Locations

US (1)