ClinicalTrials.gg
Not yet recruitingNCT07254533STEATO-NIRUpdated Sep 23, 2026

Diagnosis and Quantification of Hepatic Steatosis Using Near-infrared Spectroscopy

An interventional study of Near-infrared spectrometer in Hepatic Transplantation and Steatohepatitis, sponsored by Assistance Publique Hopitaux De Marseille. Not yet recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

In liver transplantation, the main problem is the shortage of grafts due to the small pool of donors. In order to increase the number of donors, grafts are increasingly being taken from older donors, known as 'expanded criteria' donors, who have liver steatosis lesions. Currently, expanded criteria donors account for 75% of liver transplants, whereas in 2009 they accounted for less than 30% of liver transplants.

Steatosis and its progression Non-alcoholic steatohepatitis (NASH) is an emerging disease in industrialised countries due to obesity, and corresponds to the accumulation of intracytoplasmic triglycerides.

Steatosis is diagnosed when this fat content represents more than 5% of the total liver mass. There are two types of steatosis: microvesicular steatosis and macrovacuolar steatosis, defined by the presence of lipid droplets larger than the nucleus with a nucleus displaced to the periphery. Macrovacuolar steatosis is responsible for impaired liver function if it is present in ≥30% of hepatocytes. It is a factor in poor prognosis for liver transplants, with reduced graft and recipient survival and an increase in early graft dysfunction after liver transplantation. The quantification of hepatic steatosis is based on the pathological analysis of a liver biopsy, which is currently the gold standard.

This technique has disadvantages: it is an invasive method, requiring an experienced pathologist, and presents inter-individual variability in the assessment and quantification of steatosis.

It is therefore essential to develop new non-invasive diagnostic tools that can identify the presence of steatosis > 5% and ≥ 30%. Several non-invasive techniques for diagnosing steatosis have been studied: Fibroscan, CT scan, MRI, but none of those studied previously allow for the accurate quantification of hepatic steatosis, particularly macrovacuolar steatosis, with instant results.

02

Conditions studied

  • Hepatic Transplantation
  • Steatohepatitis

Browse trials for

03

In context

Fatty Liver

662 studies on the registry are indexed under Fatty Liver; 184 are open to participants now.

This study's planned enrollment of 90 is above the median of 60 across 431 interventional studies indexed under Fatty Liver.

Browse Fatty Liver studies →

Lead sponsor

Assistance Publique Hopitaux De Marseille is the lead sponsor of 702 studies on the registry; 139 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
No

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

Liver grafts:

  • Men or women aged 18 and over
  • All donors accepted by the MA4FC procurement team, including brain-dead donors and Maastricht 3 donors, even if placed on a perfusion machine
  • Donors whose families have received information about the study and have not expressed any opposition

Surgical specimens (hepatectomy):

  • Men or women aged 18 years and older
  • Subjects who have undergone surgery for any indication of hepatectomy
  • Affiliated with social security,
  • Having received information about the study and not having expressed opposition

Exclusion criteria

Exclusion Criteria:

Liver grafts:

  • Donors whose liver will be subject to a SPLIT procedure
  • Donors for whom there is a medical-legal obstacle
  • Donors whose family or loved ones oppose scientific sampling: The hospital coordination team will consult the national refusal register and question loved ones to determine whether the deceased would have opposed sampling. If the donor and/or family oppose scientific sampling, then sampling will not be performed.

Surgical specimens (hepatectomy):

  • Subjects covered by Articles L1121-5 to 1121-8 of the Public Health Code (minors, adults under guardianship or curatorship, patients deprived of their liberty, pregnant or breastfeeding women),
  • Subjects who do not understand the French language
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    liver grafts

    Device: Near-infrared spectrometer

  • Experimental
    Surgical specimens (hepatectomy)

    Device: Near-infrared spectrometer

Interventions

  • DeviceNear-infrared spectrometer

    Scan of the liver via near-infrared spectrometer

06

What researchers measure

Primary outcomes

  1. Sensibility of near-infrared spectroscopy

    Estimate the performance of near-infrared spectroscopy for quantifying hepatic steatosis (\>5%).

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Specificity of the near-infrared spectroscopy

    Time frame: From enrollement to the end of the study at 12 months

  2. Youden's index of the near-infrared spectroscopy

    Time frame: From enrollement to the end of the study at 12 months

  3. Likelihood index + and - of the near-infrared spectroscopy

    Time frame: From enrollment to the end of the study at 12 months

  4. Nanogram likelihood ratio of the near-infrared spectroscopy

    Time frame: From enrollement to the end of the study at 12 months

  5. ROC curve of the near-infrared spectroscopy

    Time frame: From enrollement to the end of the study at 12 months

07

Study locations

1 site
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07254533
Responsible party
Sponsor
First posted
Nov 28, 2025
Start date
Jan 2027 (estimated)
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Sep 23, 2026

Study contacts

Sophie Chopinet, Dr
Contact
promotion.interne@ap-hm.fr
0491435817 ext. +33

Oversight

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

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion