NCT07690462Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 120 (estimated)
- First submitted
- 1 Jul 2026
- Start date
- Jul 2026
- Primary completion date
- Dec 2027
- Lead sponsor
- Xiangya Hospital of Central South University
- Diseases
- Prostate cancer
- NCT number
- NCT07690462
What you commit to
- Study type: Observational
- Planned participants: 120
- From Jul 2026 to the primary completion date, Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.).
Other illness
- Patients in the acute infection phase or febrile period.
- Patients with severe bleeding tendency conditions who are unable to undergo biopsy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Male
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xiangya Hospital Central South University Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.