Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma

Early Phase 1

• Conditions: Insulinoma
• Interventions: Drug: 68Ga-NOTA-MAL-Cys39-exendin-4

• Registration Number: NCT04185350
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

Brief Summary

Glucagon-like peptide-1 receptor (GLP-1R) is a kind of G protein coupled receptor which regulate the insulin secretion and serves as potential target in the diagnosis of functional pancreas neuroendocrine tumor. The aim of this study was the clinical evaluation of a potential GLP-1R targeted tracer 68Ga-NOTA-MAL-Cys39-exendin-4 for the detection of insulinoma.

Detailed Description

Since GLP-1R is expressed in human β-cells and highly overexpressed in insulinomas，multiple GLP-1R-targeted radiopharmaceuticals were devoted to insulinoma localization imaging.68Ga-NOTA-MAL-Cys39-exendin-4 is an optimal probe targeting GLP-1R. A single dose of 111-185 Mega-Becquerel (MBq) 68Ga-NOTA-MAL-Cys39-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.The investigators will determine the use of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging.

Study Timeline

• Study Start: 2019-05-05
• Status Verified: 2019-12
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Last Update Submitted: 2019-12-01
• Study First Posted: 2019-12-04
• Last Update Posted: 2019-12-04
• Primary Completion: 2020-04-05
• Study Completion: 2020-05-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. The patient volunteers and signs an informed consent form.
2. age ≥18 and ≤75 years old;
3. Patients with hypoglycaemia in the presence of neuroglycopenic symptoms and documented Whipple's triad;
4. Biochemically proven endogenous hyperinsulinemic hypoglycaemia (plasma glucose concentration <3.0 mM, insulin >3 µU/ml, and C-peptide >0.6 ng/ml);
5. Conventional imaging within 3 month.

Exclusion Criteria

1. Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;
2. Breast feeding;
3. Pregnancy or the wish to become pregnant within 6 months;
4. Renal function: serum creatinine > 3.0 mg/dl;
5. Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT	68Ga-NOTA-MAL-Cys39-exendin-4	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.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value	1 year	Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma

Secondary Outcome Measures

Name	Time	Method
Incidence of Adverse Events	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
GLP-1 receptor expression by histology compared to tracer uptake	1 year	Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China