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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Peking Union Medical College Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT02560376
First Posted: September 25, 2015
Last Update Posted: September 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital
  Purpose
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.

Condition Intervention Phase
Insulinoma Nesidioblastosis Drug: 68Ga-NOTA-exendin-4 Early Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 68Ga-NOTA-exendin-4 PET/CT for the Localization of Insulinoma and Diagnosis of Nesidioblastosis

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College Hospital:

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

Secondary Outcome Measures:
  • Adverse events collection [ Time Frame: 1 week ]
    Adverse events within 1 week after the injection and scanning of patients will be followed and assessed


Estimated Enrollment: 100
Study Start Date: February 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: 68Ga-NOTA-MAL-cys40-exendin-4

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.
  Eligibility

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Ages Eligible for Study:   6 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02560376


Contacts
Contact: Fang Li, MD +86 10 69155502 lifang@pumch.cn
Contact: Yaping Luo, MD +86 10 69155502 luoyaping@live.com

Locations
China, Beijing
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China, 100730
Contact: Fang Li, MD    +86 10 69155502    lifang@pumch.cn   
Contact: Yaping Luo, MD    +86 10 69157033    luoyaping@live.com   
Principal Investigator: Fang Li, MD         
Principal Investigator: Shawn Chen, PHD         
Sponsors and Collaborators
Peking Union Medical College Hospital
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
  More Information

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02560376     History of Changes
Other Study ID Numbers: PUMCHNM12
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Submitted: September 24, 2015
First Posted: September 25, 2015
Last Update Posted: September 25, 2015
Last Verified: May 2015

Keywords provided by Peking Union Medical College Hospital:
PET/CT
glucagon-like peptide-1 receptor (GLP-1R) imaging

Additional relevant MeSH terms:
Insulinoma
Nesidioblastosis
Adenoma, Islet Cell
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Congenital Hyperinsulinism
Infant, Newborn, Diseases
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hypoglycemia
Exenatide
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists