Prostate CancerNCT05672485
99mTc-P137 SPECT/CT in Prostate Cancer
A study testing SPECT/CT imaging with 99mTc-P137 nuclide probe in people with Prostate Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- SPECT/CT imaging with 99mTc-P137 nuclide probe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2023to 31 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Rui Gao, 0086-13772488039, jacky_mg@xjtufh.edu.cn
Xinru Li, 0086-15991432495, lixinru@xjtu.edu.cn
About this study
Official title: 99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of 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.
Read more
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
- Being tested
- SPECT/CT imaging with 99mTc-P137 nuclide probe
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPECT/CT imaging with 99mTc-P137 nuclide probeDiagnostic test
inject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with prostate cancer | Experimental | Not described Receives: Diagnostic Test: SPECT/CT imaging with 99mTc-P137 nuclide probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours after injection
Secondary outcomes (1)
Other imaging findings
CT, PET/CT, SPECT/CT and MRI will be used to evaluate the lesion scope, size and metastasis of the tumor
Measured: 7 days with the injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2023
- Study start5 Jan 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rui Gao, Study chair, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05672485
- Sponsor's protocol ID
- XJTU1AF2022LSK-356
- Status last verified
- Dec 2022
- First submitted
- 3 Jan 2023
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 99mTc-P137 SPECT/CT Molecular Probe in Precise Diagnosis of Prostate Cancer
- ClinicalTrials.gov ID
- NCT05672485
- Acronym / sponsor ID
- XJTU1AF2022LSK-356
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 5 Jan 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 5 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with prostate cancer | Experimental | Diagnostic Test: SPECT/CT imaging with 99mTc-P137 nuclide probe |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SPECT/CT imaging with 99mTc-P137 nuclide probeinject the tracer 99mTc-P137 to subjects and perform SPECT/CT scans | Diagnostic test | Patients diagnosed with prostate cancer |
Primary outcome
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)
1 secondary outcome
Other imaging findings
Time frame: 7 days with the injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rui Gao study chair
First Affiliated Hospital Xi'an Jiaotong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPECT/CT imaging with 99mTc-P137 nuclide probe in people with Prostate Cancer, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Gao (0086-13772488039, jacky_mg@xjtufh.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
99mTc-P137 SPECT/CT imaging (time frame: 2 hours after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.