99mTc-P137 SPECT/CT in Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672485
• Other study ID #: XJTU1AF2022LSK-356
• Status: Recruiting
• Phase: N/A
• Start date: January 5, 2023
• Est. completion date: January 31, 2027

Study information

• Verified date: December 2022
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: Rui Gao
• Phone: 0086-13772488039
• Email: jacky_mg[@]xjtufh.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	99mTc-P137 SPECT/CT imaging	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)	2 hours after injection
Secondary	Other imaging findings	CT, PET/CT, SPECT/CT and MRI will be used to evaluate the lesion scope, size and metastasis of the tumor	7 days with the injection