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NCT07885423Recruiting

68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer

Clinical Evaluation of the ACP3-Targeted Dual-Modality PET/Fluorescence Imaging Probe 68Ga-XMFH01 for Preoperative Imaging and Intraoperative Surgical Guidance in Prostate Cancer

Source: ClinicalTrials.gov · Last updated 26 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
25 (estimated)
First submitted
14 Oct 2026
Start date
21 Oct 2026
Primary completion date
30 Sept 2027
Lead sponsor
The First Affiliated Hospital of Xiamen University
NCT number
NCT07885423

What you commit to

  • Study type: Interventional
  • Planned participants: 25
  • From 21 Oct 2026 to the primary completion date, 30 Sept 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer.

Other

  • 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;

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affiliated hospital of Xiamen University
Coordinator of this site? Confirm its status
XiamenChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.