pre-operative imaging to detect tumours in patients with AHH using the radiactive labeled exendin-4

68Ga-NODAGA-exendin-4 PET/CT in patients with AHH - a prospective comparative evaluation of preoperative imaging Under the FP7 project Betacure (602812); Personalized diagnosis and treatment of hyperinsulinemic hypoglycaemia caused by betacell pathology - GLP-l-AHH

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-003167-38-NL

Enrollment

Registered

2015-01-07

Start date

2015-04-28

Completion date

Unknown

Last updated

2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult endogenous hyperinsulinemic hypoglycemia

Interventions

Product Name: 68Ga-NODAGA-exendin-4 Pharmaceutical Form:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Biochemically proven endogenous hyperinsulinemic hypoglycemia: neuroglycopenic symptoms in the fasting state with low plasma glucose, inappropriately high serum insulin and C-peptide concentrations • Signed informed consent • Standard imaging not older than 8 weeks. This includes a triple-phase CT or MRI, somatostatin receptor imaging (68Ga-DOTATOC, 68Ga-DOTATATE or 111In-DTPA-octreotide SPECT/CT) and endocopic ultrasound (EUS). Protocols that should be followed for these procedures can be found in the annex. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 56 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: • 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

Design outcomes

Primary

Measure	Time frame
Main Objective: The main study aim is the comparison of 68Ga-NODAGA-exendin-4 (alternatively 111In-DTPA-Exendin-4) with 68Ga-DOTATOC PET/CT (alternatively 68Ga-DOTATATE or 111In-DTPA-octreotide)) in order to determine the sensitivity and (specificity) of new imaging method as well as 68Ga-DOTATOC PET/CT for preoperative visualization of diseased beta cells. We will assess the positive predictive values and diagnostic odds ratio of the different techniques according to intra-operative findings, histology and clinical outcome. ;Secondary Objective: The secondary objectives are: •Comparison of 68Ga-NODAGA-exendin-4 (alternatively 111In-DTPA-Exendin-4) with standard imaging (eg. triple phase CT, MRI, endoscopic ultrasound) •Calculating the organ- and effective dose of 68Ga-NODAGA-exendin 4 on the basis of quantification of serial PET images in a subgroup of 6 patients. •Impact on clinical management of GLP-1R imaging, e.g. possible use of GLP-1R imaging as standard for preoperative imaging in AHH. •Calculating and comparing the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT (alternatively 111In-DTPA-AHX-Lys40-Exendin 4 SPECT/CT) combined with triple phase CT or MRI •Comparing imaging parameters (SUVmax), intraoperative findings, histology and GLP-1/sst2 receptor expression by in vitro autoradiography on frozen tissue samples ;Primary end point(s): Comparison of sensitivity, specificity, positive predictive value, diagnostic odds ratio and receiver operating characteristics between 68Ga-NODAGA-exendin 4 (alternatively 111In-DTPA-Exendin 4) and conventional imaging such as triple phase CT, MRI, F-18-DOPA, C-11-HTP and 68Ga-DOTATOC (alternatively 68Ga-DOTATATE-PET/CT or 111In-DTPA-octreotide) in adult patients with biochemically proven endogenous hyperinsulinemic hypoglycemia in the fasting state.;Timepoint(s) of evaluation of this end point: After collection of data from each patient and at the end of the study	—

Measure

Time frame

Main Objective: The main study aim is the comparison of 68Ga-NODAGA-exendin-4 (alternatively 111In-DTPA-Exendin-4) with 68Ga-DOTATOC PET/CT (alternatively 68Ga-DOTATATE or 111In-DTPA-octreotide)) in order to determine the sensitivity and (specificity) of new imaging method as well as 68Ga-DOTATOC PET/CT for preoperative visualization of diseased beta cells. We will assess the positive predictive values and diagnostic odds ratio of the different techniques according to intra-operative findings, histology and clinical outcome. ;Secondary Objective: The secondary objectives are: •Comparison of 68Ga-NODAGA-exendin-4 (alternatively 111In-DTPA-Exendin-4) with standard imaging (eg. triple phase CT, MRI, endoscopic ultrasound) •Calculating the organ- and effective dose of 68Ga-NODAGA-exendin 4 on the basis of quantification of serial PET images in a subgroup of 6 patients. •Impact on clinical management of GLP-1R imaging, e.g. possible use of GLP-1R imaging as standard for preoperative imaging in AHH. •Calculating and comparing the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT (alternatively 111In-DTPA-AHX-Lys40-Exendin 4 SPECT/CT) combined with triple phase CT or MRI •Comparing imaging parameters (SUVmax), intraoperative findings, histology and GLP-1/sst2 receptor expression by in vitro autoradiography on frozen tissue samples ;Primary end point(s): Comparison of sensitivity, specificity, positive predictive value, diagnostic odds ratio and receiver operating characteristics between 68Ga-NODAGA-exendin 4 (alternatively 111In-DTPA-Exendin 4) and conventional imaging such as triple phase CT, MRI, F-18-DOPA, C-11-HTP and 68Ga-DOTATOC (alternatively 68Ga-DOTATATE-PET/CT or 111In-DTPA-octreotide) in adult patients with biochemically proven endogenous hyperinsulinemic hypoglycemia in the fasting state.;Timepoint(s) of evaluation of this end point: After collection of data from each patient and at the end of the study

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Secondary

Measure	Time frame
Secondary end point(s): • Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4 • Assessing the impact on clinical management of GLP-1R imaging • Calculation and comparison of the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT (alternatively 111In-DTPA-AHX-Lys40-Exendin 4 SPECT/CT) and EUS combined with triple phase CT or MRI • Comparison of imaging parameters (SUVmax), intraoperative findings, histology and GLP-1/sst2 receptor expression in vitro autoradiography on frozen tissue samples ;Timepoint(s) of evaluation of this end point: After collection of data of all patients	—

Measure

Time frame

Secondary end point(s): • Calculation of the organ- and effective dose of 68Ga-NODAGA-exendin 4 • Assessing the impact on clinical management of GLP-1R imaging • Calculation and comparison of the interobserver variability of 68Ga-NODAGA-exendin 4 PET/CT (alternatively 111In-DTPA-AHX-Lys40-Exendin 4 SPECT/CT) and EUS combined with triple phase CT or MRI • Comparison of imaging parameters (SUVmax), intraoperative findings, histology and GLP-1/sst2 receptor expression in vitro autoradiography on frozen tissue samples ;Timepoint(s) of evaluation of this end point: After collection of data of all patients

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Countries

Finland, Netherlands, Switzerland

Contacts

Public ContactMartin Gotthardt

RadboudUMC

Martin.Gotthardt@radboudumc.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026