Clinical trial · Observational
Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery
A Clinical Validation Study of Novel Infrared Fluorescence Rapid Staining Versus Conventional Frozen Section in Intraoperative Diagnosis of Prostate Cancer
NCT07690462CI-TRIAL-00117206not yet recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Novel infrared fluorescence rapid staining group
- label
- Frozen section group
- label
- Paraffin section group
Primary outcomes (1)
- measure
- Diagnostic accuracy of prostate biopsy specimens
- timeFrame
- At baseline (Single visit)
- description
- To evaluate the diagnostic accuracy of the novel rapid infrared fluorescence staining technique for prostate biopsy specimens, and to compare it with frozen section.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 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). 2. Patients whose cardiac, pulmonary, hepatic, renal, and coagulation functions are essentially normal and who are able to tolerate the biopsy procedure. 3. The patient or their legally authorized representative has signed the written informed consent form. Exclusion Criteria: 1. Patients in the acute infection phase or febrile period. 2. Patients with severe bleeding tendency conditions who are unable to undergo biopsy. 3. 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.).
References
Publications (0)
Data not yet available
No reference posted for this study.