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68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

Primary Purpose

Insulinoma, Nesidioblastosis

Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NOTA-exendin-4
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Insulinoma focused on measuring PET/CT, glucagon-like peptide-1 receptor (GLP-1R) imaging

Eligibility Criteria

6 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 1 month
  • Signed written consent
  • Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study)

Exclusion Criteria:

  • Pregnancy
  • Breastfeeding
  • Renal function: serum creatinine > 3.0 mg/dl
  • Known allergy against exendin-4
  • Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

Sites / Locations

  • Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NOTA-exendin-4 PET/CT

Arm Description

The patients were injected with 55.5-111 MBq of 68Ga-NOTA-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 30-60 min later.

Outcomes

Primary Outcome Measures

Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis

Secondary Outcome Measures

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

Full Information

First Posted
September 24, 2015
Last Updated
September 24, 2015
Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
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1. Study Identification

Unique Protocol Identification Number
NCT02560376
Brief Title
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
Official Title
68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital
Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-exendin-4 in insulinoma and nesidioblastosis patients. A single dose of 55.5-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
Detailed Description
68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The investigators will determine the use of 68Ga-NOTA-exendin-4 PET/CT in the detection of insulinomas, and to compare its diagnostic value with conventional imaging. GLP-1R imaging, specifically expressed on pancreatic beta cell surface, might help with diagnosis of different types of nesidioblastosis (ie. focal or diffuse type), and may improve the treatment strategy of nesidioblastosis. The investigator will determine the use of 68Ga-NOTA-exendin-4 PET/CT in differentiating nesidioblastosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulinoma, Nesidioblastosis
Keywords
PET/CT, glucagon-like peptide-1 receptor (GLP-1R) imaging

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
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NOTA-exendin-4 PET/CT
Arm Type
Experimental
Arm Description
The patients were injected with 55.5-111 MBq of 68Ga-NOTA-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 30-60 min later.
Intervention Type
Drug
Intervention Name(s)
68Ga-NOTA-exendin-4
Other Intervention Name(s)
68Ga-NOTA-MAL-cys40-exendin-4
Intervention Description
68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients will be followed and assessed
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 1 month Signed written consent Age above 6 years (congenital hyperinsulinemic with the symptoms onset in school age is also the subject of this study) Exclusion Criteria: Pregnancy Breastfeeding Renal function: serum creatinine > 3.0 mg/dl Known allergy against exendin-4 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
Fang Li, MD
Phone
+86 10 69155502
Email
lifang@pumch.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yaping Luo, MD
Phone
+86 10 69155502
Email
luoyaping@live.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fang Li, MD
Organizational Affiliation
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fang Li, MD
Phone
+86 10 69155502
Email
lifang@pumch.cn
First Name & Middle Initial & Last Name & Degree
Yaping Luo, MD
Phone
+86 10 69157033
Email
luoyaping@live.com
First Name & Middle Initial & Last Name & Degree
Fang Li, MD
First Name & Middle Initial & Last Name & Degree
Shawn Chen, PHD

12. IPD Sharing Statement

Learn more about this trial

68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

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