Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in China / NCT05672485
Recruiting Not applicable

99mTc-P137 SPECT/CT in Prostate Cancer

NCT05672485 · tracked via the Priya Life Science China tracker
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
Phase
Not applicable
Started
2023-01-05
Last updated
2023-02-23

Condition(s) studied

Prostate Cancer

Investigational drug(s) / intervention(s)

SPECT/CT imaging with 99mTc-P137 nuclide probe

SPECT/CT imaging with 99mTc-P137 nuclide probe: inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans

Study summary

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.

Eligibility

Sex
MALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 99mTc-P137 SPECT/CT imaging — 2 hours after injection
    Qualitative and semi-quantitative analysis (T/N ratio of tumor lesion and adjacent normal tissue, changes in uptake of lesion of interest before and after treatment, and early and late imaging)

Trial sites (1)

FacilityCityRegionStatus
First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi Recruiting

More First Affiliated Hospital Xi'an Jiaotong University trials in China

Prognosis of Patients With Infective Endocarditis and Risk Stratification Value of Biomarkers (ENDEAVOR） Recruiting
Neoadjuvant PDT in the Treatment of Cholangiocarcinoma Starting soon
Clinical Characteristics and Prognosis of Aortic Dissection in China (CLASSIC) Recruiting
Magnetic Resonance Imaging Study on Young and Middle-aged Patients With Cervical Spondylotic Pain Recruiting
Safety and Efficacy of Remote Ischemic Conditioning for Patients Taking Off-pump Coronary Artery Bypass Grafting Recruiting

Other trials for the same condition

Sequential Study of 225Ac-LNC1011 in the Treatment of Metastatic Castration-Resistant Prostate Cancer Recruiting
Infrared Fluorescence Staining Versus Frozen Section for Prostate Cancer Surgery Starting soon
PSMA-PET/MRI-Ultrasound Multimodal Fusion Navigation for Da Vinci Robot-Assisted Radical Prostatectomy: A Randomized Controlled Trial Starting soon
Establishment and Promotion of an AI-Based Early Warning System for Prostate and Bladder Cancer Screening in the Male Community Population of Beijing Recruiting
Evaluation of Perilesional Biopsy in Diagnosis of Prostate Cancer Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05672485 on ClinicalTrials.gov ↗ ← All trials in China