DRUG
68Ga-NOTA-exendin-4
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
Status
Unknown
Phase
Phase 1
Enrollment
60
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
The small insulinoma can not be detected by the CT or MRI. We use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. And the diagnostic value will be performed. A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Full detailed description
The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated. And the comparation between PET diagnostic value and CT / MRI will be done.
Interventions
Treatment arms and agents.
Timeline
From registration to results.
First posted
Jul 28, 2021
Study start
Aug 1, 2020
Primary completion
Aug 1, 2025
Study completion
Aug 1, 2025
Results posted
Not reported
Registry updated
Sep 21, 2023
Outcomes
What the study measures.
Primary outcomes
Standard uptake value (SUV)
Time frame · From right after tracer injection to 1-hours post-injection
Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE Standard uptake value (SUV) of the lesion will be recorded
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 6 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent Exclusion Criteria: * 1\. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy
Study locations
1 registered sites.
China. Showing up to 24 locations stored in the fast local snapshot.
Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.