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New PET scans could sharpen bladder cancer diagnosis

NCT ID NCT06421142

Diagnosis Sponsor: First Affiliated Hospital of Fujian Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares three imaging methods—FAPI PET/MRI, FDG PET/MRI, and MRI—to see which best detects muscle-invasive bladder cancer and tracks how well pre-surgery treatment works. Researchers will enroll 80 participants with suspected or confirmed bladder cancer. The goal is to improve accuracy so doctors can tailor treatments more effectively.

What this could mean

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

Active substance
68Ga-FAPI and 18F-FDG tracers (imaging agents)
What this could lead to
If successful, this could lead to more accurate diagnosis of muscle-invasive bladder cancer and better prediction of whether neoadjuvant therapy is working, helping doctors adjust treatment sooner.
What could go wrong
This is a small, early-stage study (80 participants) focused on imaging accuracy, not treatment. The results may not apply to all patients, and the imaging techniques are not yet standard practice.

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 80 people

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

Started

Aug 2024

Expected to finish

Jun 2029

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 to 80 years

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: * Inclusion criteria for MIBC diagnostic studies 1. Patients with suspected muscle-invasive bladder cancer; 2. Completion of FAPI PET/MRI, FDG PET/MRI and MRI; 3. Complete clinical laboratory and pathological data. * Inclusion criteria for MIBC neoadjuvant therapy efficacy evaluation study 1. Patients diagnosed with muscle invasive bladder cancer; 2. Completion of FAPI PET/MRI, FDG PET/MRI, and MRI before neoadjuvant therapy; 3. Complete clinical laboratory and pathological data. Exclusion Criteria: * Exclusion criteria for MIBC diagnostic study 1. Combined with other malignant tumors; 2. Not receiving surgical treatment; 3. Receiving neoadjuvant therapy before surgery; 4. Previous allergy to contrast components or similar components; 5. Serious organ function abnormalities, such as heart, lung, liver, kidney function serious abnormalities; 6. Incomplete clinicopathological data * Exclusion criteria of MIBC neoadjuvant therapy efficacy evaluation study 1. Combination of other malignant tumors; 2. FAPI PET/MRI, FDG PET/MRI and MRI were not completed after neoadjuvant therapy; 3. Prior hypersensitivity to contrast components or similar components; 4. Serious organ function abnormalities, such as serious abnormalities of heart, lung, liver and kidney function; 5. Incomplete clinicopathological data.

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Conditions

The condition(s) this trial relates to.

infiltrating bladder urothelial carcinoma urinary bladder neoplasm Urinary Bladder Neoplasms

As listed by the trial registrant

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

Urinary bladder neoplasms

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

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    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

  • first hospital affiliated of Fujian medical university

    RECRUITING

    Fuzhou, Fujian, 350005, China

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