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

Insulinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04185350
• Other study ID #: NJCNMC-GLP-1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 5, 2019
• Est. completion date: May 5, 2020

Study information

• Verified date: December 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: Feng Wang, Ph.D
• Phone: +8602552271491
• Email: fengwangcn[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 5, 2020
• Est. primary completion date: April 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulinoma

Intervention

Drug:
• 68Ga-NOTA-MAL-Cys39-exendin-4
After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.

Locations

Country	Name	City	State
China	Nanjing First Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standardized uptake value	Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma	1 year
Secondary	GLP-1 receptor expression by histology compared to tracer uptake	Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT	1 year
Secondary	Incidence of Adverse Events	This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting	Adverse events within 1 week after the injection and scanning of patients will be followed and assessed