Using a radioactive probe to improve prostate cancer imaging
99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer
This study is testing a new imaging method using a special radioactive probe to see if it can help doctors find and understand prostate cancer better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | First Affiliated Hospital Xi'an Jiaotong University Academic / other |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT05672485 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of a radionuclide labeled molecular probe, 99mTc-P137, in conjunction with SPECT/CT imaging to enhance the diagnostic accuracy for prostate cancer. The research aims to optimize imaging techniques and clinical diagnosis processes, focusing on early detection, accurate tumor staging, and treatment decision-making. By analyzing patients who meet specific inclusion criteria, the study seeks to establish the clinical value of this innovative imaging approach in identifying prostate cancer lesions.
Who should consider this trial
Good fit: Ideal candidates include patients aged 18 and older who are highly suspicious for prostate cancer based on specific PSA levels or family history.
Not a fit: Patients with a history of other malignant tumors or severe liver and kidney dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and earlier detection of prostate cancer, improving patient outcomes.
How similar studies have performed: While the specific use of 99mTc-P137 is novel, similar imaging approaches have shown promise in enhancing prostate cancer diagnostics.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * there are other malignant tumor history; * 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.
Where this trial is running
Xi'an, Shaanxi
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Rui Gao
- Email: jacky_mg@xjtufh.edu.cn
- Phone: 0086-13772488039
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.