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NCT Number: NCT05672485

99mTc-P137 SPECT/CT in Prostate Cancer

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SPECT/CT imaging with 99mTc-P137 nuclide probe

Diagnostic Test

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

Primary outcomes

  1. 99mTc-P137 SPECT/CT imaging

    Time frame: 2 hours after injection

    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)

Secondary outcomes

  1. Other imaging findings

    Time frame: 7 days with the injection

    CT, PET/CT, SPECT/CT and MRI will be used to evaluate the lesion scope, size and metastasis of the tumor

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Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Jan 5, 2023
Registry last updated
Feb 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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