Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Clinical Validation Study of Novel Infrared Fluorescence Rapid Staining Versus Conventional Frozen Section in Intraoperative Diagnosis of Prostate Cancer
Overview
This study aims to validate the accuracy of the infrared fluorescence rapid detection technique for the diagnosis of prostate biopsy specimens, and to compare it with intraoperative frozen section and conventional paraffin section (the gold standard), so as to evaluate its feasibility and value in clinical application.
Primary outcome measures
- Diagnostic accuracy of prostate biopsy specimens [Time frame: At baseline (Single visit)]
Eligibility criteria
Inclusion criteria
- All adult male patients who are scheduled to undergo prostate biopsy at the Department of Urology, Xiangya Hospital due to clinical suspicion (e.g., elevated PSA, abnormal digital rectal examination, or suspicious lesions on imaging).
- Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure.
- The patient or their legally authorized representative has signed the written informed consent form.
Exclusion criteria
- Patients in the acute infection phase or febrile period.
- Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
- Patients with any serious concomitant disease that, in the investigator's opinion, may interfere with the study results or increase the patient's risk (e.g., hypertensive crisis; decompensated cardiac insufficiency; severe internal or external hemorrhoids, perianal or rectal lesions, etc.).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Other
Study locations
China · 1 center
- Xiangya Hospital Central South University — Changsha
Identifiers
NCT: NCT07690462 · 2026040848