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Recruiting Not applicable

68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer

NCT07885423 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-10-21
Last updated
2026-10-26

Condition(s) studied

Prostate Cancer (Diagnosis)ACP3PET / CT

Investigational drug(s) / intervention(s)

68Ga-XMFH01 PET/CT

68Ga-XMFH01 PET/CT: Each participant will receive a single intravenous injection of 68Ga-XMFH01, a novel HER2-targeted radiotracer, followed by PET/CT imaging to noninvasively assess HER2 expression in tumor lesions.

Study 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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Diagnostic efficacy — 1 month
    Description: The sensitivity of 68Ga-XMFH01 PET/CT were calculated to evaluate the diagnostic accuracy.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Xiamen University Xiamen Fujian Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07885423 on ClinicalTrials.gov ↗ ← All trials in China