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

NCT ID: NCT02560376

Last Updated: 2015-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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Insulinoma Nesidioblastosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

68Ga-NOTA-exendin-4

Intervention Type DRUG

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

Interventions

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68Ga-NOTA-exendin-4

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

Intervention Type DRUG

Other Intervention Names

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68Ga-NOTA-MAL-cys40-exendin-4

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

Peking Union Medical College Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fang Li, MD

Role: STUDY_CHAIR

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Locations

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Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Fang Li, MD

Role: CONTACT

+86 10 69155502

Yaping Luo, MD

Role: CONTACT

+86 10 69155502

Facility Contacts

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Fang Li, MD

Role: primary

+86 10 69155502

Yaping Luo, MD

Role: backup

+86 10 69157033

Other Identifiers

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ZIAEB000073

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PUMCHNM12

Identifier Type: -

Identifier Source: org_study_id

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