99mTc-P137 SPECT/CT in Prostate Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SPECT/CT imaging with 99mTc-P137 nuclide probe.
- Who it may be relevant to
- Registry conditions: Prostate Cancer. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer
Overview
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.
Interventions
- Diagnostic test SPECT/CT imaging with 99mTc-P137 nuclide probe
inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans
Primary outcome measures
- 99mTc-P137 SPECT/CT imaging [Time frame: 2 hours after injection]
Secondary outcome measures (1)
- Other imaging findings [Time frame: 7 days with the injection]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
China · 1 center
- First Affiliated Hospital of Xi'an Jiaotong University — Xi'an
Identifiers
NCT: NCT05672485 · XJTU1AF2022LSK-356