99mTc-P137 SPECT/CT in Prostate Cancer

NCT ID: NCT05672485

Last Updated: 2023-02-23

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-05
• Study Completion Date: 2027-01-31

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients diagnosed with prostate cancer

Group Type: EXPERIMENTAL

SPECT/CT imaging with 99mTc-P137 nuclide probe

Intervention Type: DIAGNOSTIC_TEST

inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans

Interventions

SPECT/CT imaging with 99mTc-P137 nuclide probe

inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rui Gao

Role: STUDY_CHAIR

First Affiliated Hospital Xi'an Jiaotong University

Locations

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Rui Gao

Role: CONTACT

jacky_mg@xjtufh.edu.cn

0086-13772488039

Xinru Li

Role: CONTACT

lixinru@xjtu.edu.cn

0086-15991432495

Facility Contacts

Rui Gao

Role: primary

jacky_mg@xjtufh.edu.cn

0086-13772488039

Xinru Li

Role: backup

lixinru@xjtu.edu.cn

0086-15991432495

Other Identifiers

XJTU1AF2022LSK-356

Identifier Type: -

Identifier Source: org_study_id