[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients
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|ClinicalTrials.gov Identifier: NCT04693169|
Recruitment Status : Recruiting
First Posted : January 5, 2021
Last Update Posted : January 19, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Drug: 11C-Choline||Not Applicable|
Prostate cancer (PCa) is the most common malignant tumor in the male reproductive system, and its prognosis and treatment mainly depend on the discovery of the primary disease and the early stage of metastasis, while traditional imaging and histological methods are difficult to meet the clinical requirements for the early diagnosis and accurate staging of PCa.Positron emission tomography (PET) has the characteristics of precision and non-invasive, so the development of PCa targeted molecular probe is of great significance for improving the specificity and accuracy of PCa diagnosis.
PSMA is a highly specific prostatic epithelial membrane antigen, which is highly expressed in solid tumors such as Prostate cancer. More than 90% of Prostate cancer cells express PSMA, so PSMA can be used as an important imaging target for Prostate cancer.
The radionuclides used for PET imaging include 18F (T 1/2 =109.8min), which has a suitable half-life and cyclotron preparation to enable the high yield synthesis of 18F labeled tracer, so it can be used in more patients and provided to other departments without on-site tracer production facilities.In addition, coordination labeling method is simple, easy to realize automatic synthesis technology and medicine box preparation.Therefore, 18F-labeled PSMA targeted molecular probe is a hot spot in the diagnosis of prostate cancer.
[Al18F]PSMA137 is a novel PSMA targeted tracer labeled with 18F. NOTA is used as a bifunctional chelating agent to facilitate better chelation with Al18F. It has a higher tumor uptake and a faster metabolism in normal organs with a lower background.[Al18F]PSMA137, as a novel targeted molecular probe, shows excellent properties in tumor cell uptake.This project provides research on [Al18F]PSMA137 PET/CT imaging for patients with suspected PCa, and provides basis for early diagnosis of PCa, formulation of treatment plan and efficacy evaluation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||[Al18F]PSMA137 PET/CT Imaging for PSMA-Positive Cancer Patients|
|Actual Study Start Date :||January 15, 2021|
|Estimated Primary Completion Date :||December 12, 2023|
|Estimated Study Completion Date :||December 12, 2023|
Experimental: [Al18F]PSMA137 PET/CT imaging
All study participants will be allocated to this arm (single-arm study).Study participants will undergo [Al18F]PSMA137 PET/CT scans.
1、PSMA137 labeled with [Al18F] will be used as a molecular imaging tracer for PET/CT scanning。 2、11C-choline (0.05-0.1mCi/kg) was injected intravenously in a week after the [Al18F]PSMA137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT
Other Name: 11C-CH
- SUV（standardized uptake value） [ Time Frame: 2 years ]SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （[Al18F]PSMA137） in the primary and metastatic tumor lesions by measuring SUV on PET/CT
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04693169
|Contact: Yanan Renfirstname.lastname@example.org|
|Contact: Hua Zhu, Associate Professoremail@example.com|