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99mTc-P137 SPECT/CT in Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SPECT/CT imaging with 99mTc-P137 nuclide probe
Sponsored by
First Affiliated Hospital Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • First Affiliated Hospital of Xi'an Jiaotong UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients diagnosed with prostate cancer

Arm Description

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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

Full Information

First Posted
January 3, 2023
Last Updated
February 22, 2023
Sponsor
First Affiliated Hospital Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT05672485
Brief Title
99mTc-P137 SPECT/CT in Prostate Cancer
Official Title
99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital Xi'an Jiaotong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients diagnosed with prostate cancer
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
SPECT/CT imaging with 99mTc-P137 nuclide probe
Intervention Description
inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans
Primary Outcome Measure Information:
Title
99mTc-P137 SPECT/CT imaging
Description
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)
Time Frame
2 hours after injection
Secondary Outcome Measure Information:
Title
Other imaging findings
Description
CT, PET/CT, SPECT/CT and MRI will be used to evaluate the lesion scope, size and metastasis of the tumor
Time Frame
7 days with the injection

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Gao
Phone
0086-13772488039
Email
jacky_mg@xjtufh.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Xinru Li
Phone
0086-15991432495
Email
lixinru@xjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rui Gao
Organizational Affiliation
First Affiliated Hospital Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710061
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rui Gao
Phone
0086-13772488039
Email
jacky_mg@xjtufh.edu.cn
First Name & Middle Initial & Last Name & Degree
Xinru Li
Phone
0086-15991432495
Email
lixinru@xjtu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

99mTc-P137 SPECT/CT in Prostate Cancer

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