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

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.

Study Overview

• Status: Unknown
• Conditions: Insulinoma
• Intervention / Treatment: Drug: 68Ga-NOTA-MAL-Cys39-exendin-4

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210006
      • Recruiting
      • Nanjing First Hospital
      • Contact: Pengjun Zhang, M.S; Phone Number: +8602552271456; Email: pengjunmr@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Standardized uptake value	Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nanjing First Hospital, Nanjing Medical University
• Investigators: Study Director: Feng Wang, Ph.D, The First Affiliated Hospital with Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2019
• Primary Completion (ANTICIPATED): April 5, 2020
• Study Completion (ANTICIPATED): May 5, 2020

Study Registration Dates

• First Submitted: December 1, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (ACTUAL): December 4, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2019
• Last Update Submitted That Met QC Criteria: December 1, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Adenoma; Pancreatic Neoplasms; Adenoma, Islet Cell; Insulinoma; Hypoglycemic Agents; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Obesity Agents; Incretins; Exenatide
• Other Study ID Numbers: NJCNMC-GLP-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No