TheranosticTrials.org

Clinical Trial · NCT07885423

68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer

Overview

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.

Sponsor

The First Affiliated Hospital of Xiamen University

Phase

N/A

Contacts

Haojun Chen, MD, PhD (CONTACT)

leochen0821@foxmail.com

86 18659285282

Liang Zhao, MD (CONTACT)

wzhaoliang01@163.com

18818350620

ClinicalTrials.gov

NCT07885423

Drug / Compound

XMFH01

Isotope(s):
Target(s):
  • ACP3
Ligand Class: Small Molecules

Eligibility

Inclusion

  • Patients diagnosed with prostate cancer who are scheduled to undergo surgical treatment;
  • 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 who are willing and able to comply with the study protocol, including scheduled visits, treatment procedures, and required laboratory and imaging examinations.
  • Patients with regional pelvic lymph node metastases (N1) are eligible for inclusion;

Exclusion

  • Patients who are unable to tolerate PET/CT examinations;
  • Patients who are medically unfit for or unable to tolerate the planned surgical procedure for prostate cancer.
  • 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;