Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
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|ClinicalTrials.gov Identifier: NCT04185350|
Recruitment Status : Unknown
Verified December 2019 by FengWang, Nanjing First Hospital, Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Insulinoma||Drug: 68Ga-NOTA-MAL-Cys39-exendin-4||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma|
|Actual Study Start Date :||May 5, 2019|
|Estimated Primary Completion Date :||April 5, 2020|
|Estimated Study Completion Date :||May 5, 2020|
Experimental: 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT
The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later.
After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.
- Standardized uptake value [ Time Frame: 1 year ]Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma
- GLP-1 receptor expression by histology compared to tracer uptake [ Time Frame: 1 year ]Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT
- Incidence of Adverse Events [ Time Frame: Adverse events within 1 week after the injection and scanning of patients will be followed and assessed ]This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
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): NCT04185350
|Contact: Feng Wang, Ph.Demail@example.com|
|Nanjing First Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210006|
|Contact: Pengjun Zhang, M.S +8602552271456 firstname.lastname@example.org|
|Study Director:||Feng Wang, Ph.D||The First Affiliated Hospital with Nanjing Medical University|