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Clinical evaluation of the ACP3-Targeted Dual-Modality PET/Fluorescence imaging probe 68Ga-XMFH01 for preoperative imaging and intraoperative surgical guidance in prostate cancer

NCT ID NCT07885423

Sponsor: The First Affiliated Hospital of Xiamen University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 21, 2026 · Last updated Oct 22, 2026 · Updated 1 time

Summary

This study aims to evaluate the feasibility, safety, and diagnostic performance of 68Ga-XMFH01, a novel ACP3-targeted dual-modality PET and fluorescence imaging probe, for preoperative PET/CT imaging and intraoperative fluorescence-guided surgery in patients with prostate cancer.

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 25 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Sep 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

Male participants only

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 diagnosed with prostate cancer who are scheduled to undergo surgical treatment; * Adult patients (aged 18 years or older); * No evidence of distant metastases (M0), including nonregional lymph node metastases, bone metastases, or visceral metastases, as determined by conventional imaging (bone scintigraphy, CT, or MRI) or PET/CT; * Patients with regional pelvic lymph node metastases (N1) are eligible for inclusion; * Patients who have been fully informed of their disease status, treatment options, and study procedures, and who voluntarily provide written informed consent; * Patients who are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations. Exclusion Criteria: * Patients who are unwilling or unable to provide written informed consent or cooperate with study procedures; * Patients who are unable to tolerate PET/CT examinations; * Patients who have previously received any of the following treatments for prostate cancer: (a) Systemic therapy: More than 2 months of androgen deprivation therapy (ADT) or conventional hormonal therapy, or any prior treatment with novel hormonal agents, chemotherapy, immunotherapy, or targeted therapy. (b) Local therapy: Prior pelvic radiotherapy or surgery for prostate cancer; * Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer.

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Conditions

The condition(s) this trial relates to.

disease prostate cancer

As listed by the trial registrant

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

ACP3 Pet / CT Prostate cancer (diagnosis)

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

  • The First Affiliated Hospital of Xiamen University

    RECRUITING

    Xiamen, Fujian, 361003, China

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