68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis
2 other identifiers
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Feb 2014
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 24, 2015
CompletedFirst Posted
Study publicly available on registry
September 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedSeptember 25, 2015
May 1, 2015
2.8 years
September 24, 2015
September 24, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Standardized uptake value of 68Ga-NOTA-exendin-4 PET/CT in Diagnosis of Insulinoma and Nesidioblastosis
1 year
Secondary Outcomes (1)
Adverse events collection
1 week
Study Arms (1)
68Ga-NOTA-exendin-4 PET/CT
EXPERIMENTALThe 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.
Interventions
68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Fang Li, MD
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 24, 2015
First Posted
September 25, 2015
Study Start
February 1, 2014
Primary Completion
December 1, 2016
Study Completion
December 1, 2016
Last Updated
September 25, 2015
Record last verified: 2015-05