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

NCT ID: NCT04185350

Last Updated: 2019-12-04

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

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-05

Study Completion Date

2020-05-05

Brief Summary

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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

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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.

Conditions

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Insulinoma

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-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.

Group Type EXPERIMENTAL

68Ga-NOTA-MAL-Cys39-exendin-4

Intervention Type DRUG

After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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FengWang

Director of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Feng Wang, Ph.D

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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Nanjing First Hospital

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Wang, Ph.D

Role: CONTACT

+8602552271491

Facility Contacts

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Pengjun Zhang, M.S

Role: primary

+8602552271456

Other Identifiers

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NJCNMC-GLP-1

Identifier Type: -

Identifier Source: org_study_id

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