Back to resultsClinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Primary Purpose
Insulinoma
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-MAL-Cys39-exendin-4
Sponsored by
About this trial
This is an interventional diagnostic trial for Insulinoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Nanjing First HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT
Arm Description
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.
Outcomes
Primary Outcome Measures
Standardized uptake value
Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT04185350
First Posted
December 1, 2019
Last Updated
December 1, 2019
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04185350
Brief Title
Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Official Title
Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 5, 2019 (Actual)
Primary Completion Date
April 5, 2020 (Anticipated)
Study Completion Date
May 5, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-MAL-Cys39-exendin-4
Intervention Description
After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.
Primary Outcome Measure Information:
Title
Standardized uptake value
Description
Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma
Time Frame
1 year
Secondary Outcome Measure Information:
Title
GLP-1 receptor expression by histology compared to tracer uptake
Description
Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT
Time Frame
1 year
Title
Incidence of Adverse Events
Description
This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting
Time Frame
Adverse events within 1 week after the injection and scanning of patients will be followed and assessed
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Wang, Ph.D
Phone
+8602552271491
Email
fengwangcn@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Wang, Ph.D
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210006
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pengjun Zhang, M.S
Phone
+8602552271456
Email
pengjunmr@163.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
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