NCT05672485Recruiting
99mTc-P137 SPECT/CT in Prostate Cancer
99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer
Source: ClinicalTrials.gov · Last updated 23 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Purpose: This study will take prostate specific membrane antigen (PSMA) as the targeting of radionuclide labeled molecular probe to explore the diagnostic efficacy of 99mTc-P137 radioactive probe in prostate cancer. Combining with SPECT/CT to optimize the imaging, image analysis and clinical diagnosis process of 99mTc-P137 probe, the aim of the study is to provide new methods and new means for the early detection, early diagnosis, accurate tumor staging, treatment decision and prognosis judgment of malignant tumor, and will provide scientific and clinical basis for the precise diagnosis and treatment of prostate cancer. Research objectives: To investigate the clinical translational application value of 99mTc-P137 molecular probe in accurate detection of prostate cancer lesions. Research design: A prospective study design will be used in this study. Patients meeting the inclusion criteria of this study will be analyzed with 99mTc-P137 SPECT/CT imaging. To evaluate the diagnostic and prognostic value of 99mTc-P137 nuclear medicine imaging in accurate detection of prostate cancer lesions, clinical surgical specimens and pathological diagnosis will be used as the gold standard. Study the population Indications: For patients with suspected prostate cancer who plan to undergo surgical resection or puncture biopsy after various examinations, the final pathological results can be obtained.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 3 Jan 2023
- Start date
- 5 Jan 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Diseases
- Prostate cancer
- NCT number
- NCT05672485
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 5 Jan 2023 to the primary completion date, 31 Dec 2026
- 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.
Other illness
- there are other malignant tumor history;
Other
- severe damage of liver and kidney function;
- may not be able to obtain pathology or long-term follow-up results;
- don't have access to relevant reference image data and clinical data;
- difficult to cooperate.
Who the study is looking for
- patients age 18 or above;
- highly suspicious for prostate cancer patients: 1) Serum PSA is significantly changed compared with before (PSA\<4.0ng/mL with annual change \>0.35ng/mL; or PSA \> 4.0ng/mL with annual change \> 0.75ng/mL); 2) First or second degree relatives have a history of prostate cancer; 3) Nuclear magnetic PI-RADS score ≥3 points;
- the prostate biopsy or surgical pathology is diagnosed with prostate cancer;
- available to provide clinical laboratory results (blood routine, biochemical and serum PSA) within one month before this study; At least two imaging examinations including CT, MRI, nuclear medicine (PET/CT or SPECT/CT), ultrasound and other imaging techniques;
- Can complete the inspection autonomously;
- voluntary and signed informed consent.
Age in the registry: 18 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi'an | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.