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

NCT04185350 | Unknown Early Phase 1

• 1 other identifier: NJCNMC-GLP-1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Insulinoma

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value

  Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma

  1 year

Secondary Outcomes (2)

• GLP-1 receptor expression by histology compared to tracer uptake

  1 year

• Incidence of Adverse Events

  Adverse events within 1 week after the injection and scanning of patients will be followed and assessed

Study Arms (1)

68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT

EXPERIMENTAL

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

Interventions

68Ga-NOTA-MAL-Cys39-exendin-4 DRUG

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

68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

RECRUITING

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Feng Wang, Ph.D

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

Central Study Contacts

Feng Wang, Ph.D

CONTACT

+8602552271491; fengwangcn@hotmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Nuclear Medicine

Study Record Dates

• First Submitted: December 1, 2019
• First Posted: December 4, 2019
• Study Start: May 5, 2019
• Primary Completion: April 5, 2020
• Study Completion: May 5, 2020
• Last Updated: December 4, 2019

Record last verified: 2019-12

Locations

CN (1)