Actively Recruiting

Phase Not Applicable
Age: 18Years +
MALE
NCT05672485

99mTc-P137 SPECT/CT in Prostate Cancer

Led by First Affiliated Hospital Xi'an Jiaotong University · Updated on 2023-02-23

40

Participants Needed

1

Research Sites

212 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

99mTc-P137 SPECT/CT in Prostate Cancer

Who Can Participate

Age: 18Years +
MALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Highly suspicious for prostate cancer based on any of the following: significant change in serum PSA levels (PSA <4.0 ng/mL with annual change >0.35 ng/mL or PSA >4.0 ng/mL with annual change >0.75 ng/mL), or first or second degree relatives with a history of prostate cancer, or MRI PI-RADS score 3 or above
  • Prostate biopsy or surgical pathology diagnosis of prostate cancer
  • Able to provide clinical laboratory results (blood routine, biochemical, serum PSA) within one month before the study
  • Have at least two imaging exams including CT, MRI, nuclear medicine (PET/CT or SPECT/CT), ultrasound, or other imaging techniques
  • Able to complete the inspection independently
  • Voluntary and signed informed consent
Not Eligible

You will not qualify if you...

  • History of other malignant tumors
  • Severe liver or kidney damage
  • Unable to obtain pathology or long-term follow-up results
  • Lack of access to relevant reference imaging and clinical data
  • Difficulty cooperating with the study

AI-Screening

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Trial Site Locations

Total: 1 location

1

First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China, 710061

Actively Recruiting

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Research Team

R

Rui Gao

CONTACT

X

Xinru Li

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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99mTc-P137 SPECT/CT in Prostate Cancer | DecenTrialz