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Breakthrough scan could replace kidney biopsies for fibrosis monitoring

NCT ID NCT06563765

Diagnosis Sponsor: Peking University First Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new PET/CT imaging method that uses a special dye to spot kidney scarring (fibrosis) in people with chronic kidney disease. The goal is to see if this scan can accurately measure fibrosis without needing a needle biopsy. 150 patients will be scanned, and the results will be compared to their biopsy samples. If it works, doctors could monitor kidney damage over time more safely and easily.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FAP-targeting PET/CT imaging agent (FAPI-04 and new FAP probe)
What this could lead to
If successful, this could provide a non-invasive, repeatable way to monitor kidney fibrosis, helping doctors track disease progression and guide treatment without repeated biopsies.
What could go wrong
This is an early imaging study, not a treatment trial. The new probe's accuracy in mild-to-moderate fibrosis is still being tested, and results may not change patient outcomes directly.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 150 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2024

Expected to finish

May 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with chronic kidney disease * Renal pathology was performed within 2 weeks Exclusion Criteria: * Pregnant or lactating patients

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Conditions

The condition(s) this trial relates to.

chronic kidney disease renal fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

CKD Renal fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University First Hospital

    Beijing, Beijing Municipality, China

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