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Not yet recruitingNCT07924891Updated Nov 9, 2026

Longitudinal Changes in Whole-Body MRI Phenotypes and Disease Associations

An observational study in Whole-Body MRI Imaging Phenotypes, sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Observational

Updated Nov 9, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
6,000
Ages
18 Years and older
Sex
All
01

Study summary

This observational study uses existing and newly collected clinical whole-body magnetic resonance imaging (MRI) data from adults evaluated at Union Hospital. The study will measure body composition, bone marrow fat fraction, and imaging phenotypes of multiple organs, and will examine how these measures change over time and relate to diseases and clinical outcomes. The retrospective cohort will include eligible whole-body MRI examinations performed from January 1, 2015 through August 31, 2026. The prospective cohort will enroll adults undergoing whole-body MRI for clinical indications from September 1, 2026 through August 31, 2029, with follow-up and analyses through August 31, 2030. No study-specific treatment or additional imaging is assigned; images and clinical data are analyzed under the approved protocol.

Read the detailed description

This single-center, non-interventional, observational bidirectional cohort study evaluates longitudinal changes in body composition, bone marrow fat fraction, and multiorgan imaging phenotypes derived from whole-body MRI. The retrospective cohort will use eligible whole-body MRI examinations and linked clinical data generated at Union Hospital between January 1, 2015 and August 31, 2026. The prospective cohort will enroll adults who undergo whole-body MRI for clinical indications between September 1, 2026 and August 31, 2029 and who provide written informed consent for the approved use of imaging, clinical, and follow-up data. The planned sample is approximately 6,000 participants, including approximately 5,000 retrospective and 1,000 prospective participants. No participant is assigned to a treatment, no study-specific imaging or medication is required, and routine clinical care is unchanged. Image quality control, organ and tissue segmentation, and standardized extraction of body composition, bone marrow fat, muscle, visceral and subcutaneous fat, and other organ-level phenotypes will be performed. The study will assess annualized phenotype trajectories, associations between imaging phenotypes and prevalent or incident disease, hospitalization, major clinical events, and mortality, as well as measurement repeatability, region-of-interest quality, subgroup differences, and risk prediction performance. Data will be deidentified for analysis and handled under the approved institutional ethics protocol. The retrospective component uses an approved waiver of informed consent; the prospective component requires written informed consent. Participants may withdraw prospective consent at any time. Follow-up and analyses are planned through August 31, 2030.

02

Conditions studied

  • Whole-Body MRI Imaging Phenotypes

Keywords

  • whole-body magnetic resonance imaging
  • body composition
  • bone marrow fat fraction
  • multiorgan imaging
03

In context

Lead sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology is the lead sponsor of 181 studies on the registry; 144 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults undergoing clinically indicated whole-body MRI at Union Hospital or with eligible historical whole-body MRI examinations, including retrospective and prospective cohorts. The planned enrollment is approximately 6,000 participants, with approximately 5,000 retrospective and 1,000 prospective participants.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 years or older.
  2. Retrospective cohort: completion of at least one eligible whole-body MRI examination at Union Hospital between January 1, 2015 and August 31, 2026, with sufficient image quality and linked clinical data for analysis.
  3. Prospective cohort: scheduled for whole-body MRI for a clinical indication at Union Hospital between September 1, 2026 and August 31, 2029, able to understand the study and provide written for approved use of imaging, clinical, and follow-up data.
  4. At least one prespecified imaging phenotype or quality-control measure can be reliably obtained.

Exclusion criteria

Exclusion Criteria:

  1. Severe image artifacts, incomplete coverage, missing sequences, or other technical limitations that prevent reliable calculation of a prespecified phenotype.
  2. Patient identity, examination date, sequence identity, or source data cannot be reliably matched or verified.
  3. Key source data are corrupted, unreadable, or unavailable.
  4. Prospective participants who withdraw or are judged by the clinical team unable to complete the planned MRI examination.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
6,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Retrospective Cohort

    Adults aged 18 years or older with eligible whole-body MRI examinations and linked clinical data generated at Union Hospital from January 1, 2015 through August 31, 2026. This cohort uses existing records and images; no study-specific intervention is assigned.

  • Prospective Cohort

    Adults aged 18 years or older who undergo whole-body MRI for clinical indications at Union Hospital from September 1, 2026 through August 31, 2029 and provide written informed consent for use of imaging, clinical, and follow-up data. No study-specific intervention is assigned.

06

What researchers measure

Primary outcomes

  1. Annualized change in mean vertebral bone marrow fat fraction

    Vertebral bone marrow fat fraction will be measured from water-fat MRI within independently validated marrow regions of interest (ROIs), excluding cortical bone and non-marrow soft tissue. A single value is the arithmetic mean across the prespecified vertebral marrow ROIs, using the same vertebral levels in each paired examination. Annualized change is the later mean minus the earlier mean, divided by the elapsed time in years. The reported unit is percentage points/year. Only quality-controlled paired measurements are included.

    Time frame: From the first eligible MRI to subsequent clinically indicated repeat MRI examinations; intervals vary by participant. Retrospective records: Jan 2015-Aug 2026; prospective observation: through Aug 31, 2030.

  2. Annualized change in visceral adipose tissue volume

    Whole-body MRI with automated or semiautomated visceral adipose tissue segmentation and manual quality review. For each eligible pair of MRI examinations, annualized change is calculated as the later value minus the earlier value, divided by the elapsed time in years. The reported unit is L/year. Only paired measurements passing phenotype-specific quality control are included.

    Time frame: From the first eligible MRI to subsequent clinically indicated repeat MRI examinations; intervals vary by participant. Retrospective records: Jan 2015-Aug 2026; prospective observation: through Aug 31, 2030.

  3. Annualized change in skeletal muscle volume

    Whole-body MRI with automated or semiautomated skeletal muscle segmentation and manual quality review. For each eligible pair of MRI examinations, annualized change is calculated as the later value minus the earlier value, divided by the elapsed time in years. The reported unit is L/year. Only paired measurements passing phenotype-specific quality control are included.

    Time frame: From the first eligible MRI to subsequent clinically indicated repeat MRI examinations; intervals vary by participant. Retrospective records: Jan 2015-Aug 2026; prospective observation: through Aug 31, 2030.

Secondary outcomes

  1. Repeatability of mean vertebral bone marrow fat fraction assessed by intraclass correlation coefficient

    The absolute-agreement intraclass correlation coefficient (ICC) will quantify agreement between independent repeated measurements of mean vertebral bone marrow fat fraction from the same MRI dataset in the measurement-validation subset. Water-fat MRI within independently validated vertebral marrow regions of interest (ROIs), excluding cortical bone and non-marrow soft tissue. A single participant-level value is the arithmetic mean across the prespecified vertebral marrow ROIs. The same vertebral levels must contribute to both examinations. The underlying measurement is expressed in percent (%). The reported outcome is one ICC for this phenotype, without units. A value closer to 1 indicates better agreement. Longitudinal biological change between scans separated by months or years is not used as a measure of measurement repeatability.

    Time frame: At repeat quantification of the same eligible MRI dataset in the measurement-validation subset; no additional scan or participant visit.

  2. Time to death from any cause

    This outcome is the elapsed time in days from the index MRI to death from any cause. Death status and date will be ascertained from electronic medical records and available routine follow-up information, including clinical confirmation where necessary. Participants not known to have died will be censored at the last date they were known to be alive or August 31, 2030, whichever occurs first. Participants with unknown vital status will not be assumed alive through study completion. The reported unit is days.

    Time frame: From the first eligible MRI to the event or last available follow-up, as applicable, through August 31, 2030; observation duration varies by participant.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — There is no current plan to share individual participant data (IPD) with other researchers. The study involves sensitive MRI and clinical information, and the approved protocol specifies that the original imaging and clinical data will remain on the hospital's approved secure server. Data will be coded or de-identified and accessed only by authorized study personnel for approved analyses. Only aggregate, non-identifiable results will be reported or published. Any future request to share IPD would require an amendment to the study protocol, review and approval by the ethics committee and relevant institutional authorities, and compliance with applicable privacy and data-protection requirements.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Aug 2029, 33 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 9, 2026
First posted
Nov 9, 2026
StartEst.
Nov 1, 2026
Primary completionEst.
Aug 31, 2029
CompletionEst.
Aug 31, 2030
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 9, 2026
Show all 1 update
  1. Nov 9, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07924891
Responsible party
Sponsor
First posted
Nov 9, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Aug 31, 2029 (estimated)
Completion
Aug 31, 2030 (estimated)
Last update
Nov 9, 2026

Study contacts

Lian Yang
Contact
yanglian@hust.edu.cn
+86 18986273791
Lian Yang
principal investigator · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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