An interventional study of 68Ga-XMFH01 PET/CT in Prostate Cancer (Diagnosis), ACP3 and PET / CT, sponsored by The First Affiliated Hospital of Xiamen University. Recruiting at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by The First Affiliated Hospital of Xiamen University · Not applicable, Interventional, and Treatment
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.
68Ga-XMFH01 is a novel ACP3-targeted dual-modality imaging probe with promising potential for prostate cancer detection and intraoperative surgical guidance. In this prospective study, patients with newly diagnosed prostate cancer will undergo preoperative 68Ga-XMFH01 PET/CT for initial disease assessment. Tracer uptake in tumor lesions will be quantified using the maximum standardized uptake value (SUVmax). During surgery, fluorescence imaging will be performed to identify tumor lesions and assess surgical margin status. The concordance between fluorescence-based surgical margin assessment (positive or negative) and histopathological findings will be evaluated. Following surgery, the diagnostic accuracy of 68Ga-XMFH01 PET/CT will be assessed using histopathological findings from resected specimens as the reference standard. The feasibility and safety of this dual-modality imaging approach will also be evaluated.
6,484 studies on the registry are indexed under Prostatic Neoplasms; 1,415 are open to participants now.
This study's planned enrollment of 25 is below the median of 58 across 4,908 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →The First Affiliated Hospital of Xiamen University is the lead sponsor of 118 studies on the registry; 79 are open to participants now.
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Exclusion Criteria:
Participants will undergo preoperative 68Ga-XMFH01 PET/CT imaging for tumor detection and localization, followed by intraoperative fluorescence-guided surgical navigation using the same dual-modality probe.
Diagnostic Test: 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.
Diagnostic efficacy
Description: The sensitivity, specificity, and accuracy of 68Ga-XMFH01 PET/CT were calculated to evaluate the diagnostic accuracy.
Time frame: 1 month
Concordance Between Intraoperative Fluorescence Imaging and Histopathology for Prostate Surgical Margin Assessment
The concordance between intraoperative fluorescence imaging findings (positive or negative) and postoperative histopathological results (positive or negative) will be evaluated for prostate surgical margins.
Time frame: 1 month
Concordance Between Intraoperative Fluorescence Imaging and Histopathology for Pelvic Lymph Node Assessment
The concordance between intraoperative fluorescence imaging findings (positive or negative) and postoperative histopathological results (malignant or benign) will be evaluated for pelvic lymph nodes.
Time frame: 1 month
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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