68Ga-NODAGA-exendin-4 PET/CT for Diagnostic Imaging in AHH

NCT03189953 | Completed Phase 1

• 3 other identifiers: NL50643.091.142014-003167-38602812
• Study Type: interventional
• Target: 56
• Locations: 0 countries
• Sites: N/A

Brief Summary

In order to improve the sensitivity and specificity of pre-operative imaging localization of foci in adult endogenous hyperinsulinemic hypoglycaemia (AHH) we aim to evaluate a novel promising imaging compound targeting the glucagon-like peptide-1 receptor (GLP-1R), 68Ga-NODAGA-exendin 4. With the currently used imaging techniques, only about 70-80% of insulin producing pancreatic neuroendocrine tumors (IPPNET) can be successfully visualized. Therefore, we propose to compare GLP-1R PET imaging to the standard imaging techniques in patients scheduled for surgical removal of the tumour. These highly relevant data will allow us to interpret the benefits of GLP-1R-imaging over other imaging techniques for the diagnosis of IPPNET in AHH patients. Since pre-operative localization of foci in AHH remains challenging and frequently still leading to futile surgery or unnecessary partial pancreatectomy, a more sensitive and specific imaging technique would be of great value.

Conditions

Insulinoma

Outcome Measures

Primary Outcomes (1)

• Tumor visualization by 68Ga-NODAGA-exendin-4 PET/CT and standard imaging

  1 year

Secondary Outcomes (4)

• Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4

  1 year

• Retrospective surgery planning, type of surgery based on image analysis

  1 year

• Calculation and comparison of the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT and EUS combined with triple phase CT or MRI

  up to 24 months

• GLP-1 receptor expression by histology compared to tracer uptake

  1 year

Study Arms (1)

68Ga-NODAGA-exendin PET/CT

EXPERIMENTAL

68Ga-NODAGA-exendin PET/CT

Radiation: 68Ga-NODAGA-exendin 4 PET/CT

Interventions

68Ga-NODAGA-exendin 4 PET/CT RADIATION

68Ga-NODAGA-exendin 4 PET/CT

68Ga-NODAGA-exendin PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biochemically proven endogenous hyperinsulinemic hypoglycemia
• Signed informed consent
• Standard imaging not older than 8 weeks.

You may not qualify if:

• Breast feeding
• Pregnancy or the wish to become pregnant within 6 months
• Calculated creatinine clearance below 40ml/min
• Evidence of other malignancy than insulin producing tumors in conventional imaging (suspicious liver, bone and lung lesions)
• Age \< 18 years
• No signed informed consent

Sponsors & Collaborators

• Radboud University Medical Center: lead
• University Medical Center Groningen: collaborator
• Charite University, Berlin, Germany: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator
• University College, London: collaborator
• University of Helsinki: collaborator
• University of Turku: collaborator

MeSH Terms

Conditions

Insulinoma

Condition Hierarchy (Ancestors)

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

Study Officials

• Martin Gotthardt, Prof. Dr.

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Comparison of 68Ga-NODAGA-exendin PET/CT with standard diagnostic methods

Study Record Dates

• First Submitted: April 6, 2016
• First Posted: June 16, 2017
• Study Start: April 1, 2015
• Primary Completion: January 1, 2021
• Study Completion: May 1, 2021
• Last Updated: June 16, 2021

Record last verified: 2021-06