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Clinical Trial · NCT02560376
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
Overview
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Phase
Early Phase 1
Contacts
Yaping Luo, MD (CONTACT)
luoyaping@live.com
+86 10 69155502
Fang Li, MD (CONTACT)
lifang@pumch.cn
+86 10 69155502
Fang Li, MD (STUDY_CHAIR)
ClinicalTrials.gov
NCT02560376Drug / Compound
NOTA-exendin-4
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- Glucagon-Like Peptide-1 Receptor (GLP1R)
Ligand Class: Peptides
Chelator: NOTA
Linker: MAL-cys40
Eligibility
Inclusion
- Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration \<3.0 mM, insulin \>3 µU/ml, and C-peptide \>0.6 ng/ml).
- Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad.
- Signed written consent
- Conventional imaging within 1 month
Exclusion
- Pregnancy
- Known allergy against exendin-4
- Breastfeeding
- Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
- Renal function: serum creatinine \> 3.0 mg/dl
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