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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04185350
Recruitment Status : Unknown
Verified December 2019 by FengWang, Nanjing First Hospital, Nanjing Medical University.
Recruitment status was:  Recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
Information provided by (Responsible Party):
FengWang, 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.

Condition or disease Intervention/treatment Phase
Insulinoma Drug: 68Ga-NOTA-MAL-Cys39-exendin-4 Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Actual Study Start Date : May 5, 2019
Estimated Primary Completion Date : April 5, 2020
Estimated Study Completion Date : May 5, 2020

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.

Primary Outcome Measures :
  1. Standardized uptake value [ Time Frame: 1 year ]
    Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma

Secondary Outcome Measures :
  1. GLP-1 receptor expression by histology compared to tracer uptake [ Time Frame: 1 year ]
    Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT

  2. Incidence of Adverse Events [ Time Frame: 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04185350

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Contact: Feng Wang, Ph.D +8602552271491

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China, Jiangsu
Nanjing First Hospital Recruiting
Nanjing, Jiangsu, China, 210006
Contact: Pengjun Zhang, M.S    +8602552271456   
Sponsors and Collaborators
Nanjing First Hospital, Nanjing Medical University
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Study Director: Feng Wang, Ph.D The First Affiliated Hospital with Nanjing Medical University
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Responsible Party: FengWang, Director of Nuclear Medicine, Nanjing First Hospital, Nanjing Medical University Identifier: NCT04185350    
Other Study ID Numbers: NJCNMC-GLP-1
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Adenoma, Islet Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Hormones, Hormone Substitutes, and Hormone Antagonists