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Trial Title:
99mTc-P137 SPECT/CT in Prostate Cancer
NCT ID:
NCT05672485
Condition:
Prostate Cancer
Conditions: Official terms:
Prostatic Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
SPECT/CT imaging with 99mTc-P137 nuclide probe
Description:
inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans
Arm group label:
Patients diagnosed with prostate cancer
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.
Criteria for 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.
Gender:
Male
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
First Affiliated Hospital of Xi'an Jiaotong University
Address:
City:
Xi'an
Zip:
710061
Country:
China
Status:
Recruiting
Contact:
Last name:
Rui Gao
Phone:
0086-13772488039
Email:
jacky_mg@xjtufh.edu.cn
Contact backup:
Last name:
Xinru Li
Phone:
0086-15991432495
Email:
lixinru@xjtu.edu.cn
Start date:
January 5, 2023
Completion date:
January 31, 2027
Lead sponsor:
Agency:
First Affiliated Hospital Xi'an Jiaotong University
Agency class:
Other
Source:
First Affiliated Hospital Xi'an Jiaotong University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672485
