Clinical trial NCT05672485: 99mTc-P137 SPECT/CT in Prostate Cancer
Official title: 99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2023-01-05
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: 99mTc-P137 SPECT/CT imaging
timeFrame: 2 hours after injection
Secondary outcomes:
measure: Other imaging findings
timeFrame: 7 days with the injection
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Rui Gao
role: STUDY_CHAIR
References: