99mTc-P137 SPECT/CT in Prostate Cancer

Sponsor

First Affiliated Hospital Xi'an Jiaotong University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05672485

Collaborator

(none)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Diagnostic Test: SPECT/CT imaging with 99mTc-P137 nuclide probe	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Anticipated Study Start Date :

Dec 30, 2022

Anticipated Primary Completion Date :

Dec 30, 2022

Anticipated Study Completion Date :

Dec 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patients diagnosed with prostate cancer	Diagnostic Test: SPECT/CT imaging with 99mTc-P137 nuclide probe inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans

Arm

Intervention/Treatment

Experimental: Patients diagnosed with prostate cancer

Diagnostic Test: SPECT/CT imaging with 99mTc-P137 nuclide probe

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

Outcome Measures

Primary Outcome Measures

99mTc-P137 SPECT/CT imaging [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 Outcome Measures

Other imaging findings [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi	China	710061

Sponsors and Collaborators

First Affiliated Hospital Xi'an Jiaotong University

Investigators

Study Chair: Rui Gao, First Affiliated Hospital Xi'an Jiaotong University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

First Affiliated Hospital Xi'an Jiaotong University

ClinicalTrials.gov Identifier:

NCT05672485

Other Study ID Numbers:

XJTU1AF2022LSK-356

First Posted:

Jan 5, 2023

Last Update Posted:

Jan 5, 2023

Last Verified:

Dec 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Prostatic Neoplasms

Study Results

No Results Posted as of Jan 5, 2023