68Ga-NOTA-exendin-4 PET/CT For The Localization Of Insulinoma And Diagnosis Of Nesidioblastosis

Study Overview

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

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.

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.

Insulinoma
Nesidioblastosis

DRUG: 68Ga-NOTA-exendin-4

PUMCHNM12
ZIAEB000073 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2015-09-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2015-09-24
First Submitted that Met QC Criteria 2015-09-24	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2015-09-25
First Posted (ESTIMATED) 2015-09-25	Results First Posted N/A	Last Verified 2015-05

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 68Ga-NOTA-exendin-4 PET/CT 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.	DRUG: 68Ga-NOTA-exendin-4 68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: 68Ga-NOTA-exendin-4 PET/CT

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.

DRUG: 68Ga-NOTA-exendin-4

68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans

Primary Outcome Measures	Measure Description	Time Frame
Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis		1 year

Secondary Outcome Measures	Measure Description	Time Frame
Adverse events collection	Adverse events within 1 week after the injection and scanning of patients will be followed and assessed	1 week

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Fang Li, MD

Phone Number: +86 10 69155502

Email: [email protected]

Study Contact Backup

Name: Yaping Luo, MD

Phone Number: +86 10 69155502

Email: [email protected]

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
6 Years

Accepts Healthy Volunteers:

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)

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Investigators

STUDY_CHAIR: Fang Li, MD, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

Patients

Caregivers

Clinical Trial Record