Endogenous Hyperinsulinaemic HypoglycaemiaNCT02127541
New Imaging Procedure for the Localisation of Insulinoma
A study testing Ga -exendin PET/CT, In- exendin SPECT/CT, MRI in people with Endogenous Hyperinsulinaemic Hypoglycaemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endogenous Hyperinsulinaemic Hypoglycaemia
- What is being tested?
- Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Jan 2014to Nov 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biochemically proven endogenous hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm
- Conventional imaging (CT,MRI or EUS) not older than 2 months
- Signed written consent
- Age above 18 years
Who cannot join
- Kidney failure (creatinine > 140micromol/l)
- Known allergies against Exendin-4 (Byetta or Bydureon)
- Pregnancy
- Breastfeeding
- Medication with Byetta or Bydureon
- Evidence for malignancy (extrapancreatic tumor manifestations)
Trial locations and contacts
1 site in 1 country.
About this study
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.
- Being tested
- Ga -exendin PET/CT, In- exendin SPECT/CT, MRI
- Keywords
- Localisation of Insulinoma, beta-cell imaging, exendin-4, 68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ga -exendin PET/CT, In- exendin SPECT/CT, MRIOther
Also called 68Ga-DOTA-exendin-4, 111In-DOTA-exendin-4, MRI
Comparison of different imaging modalities
| Study group | Role | What they receive |
|---|---|---|
| Ga -exendin PET/CT, In- exendin SPECT/CT, MRI | Experimental | This is a cross-over study comparing three imaging methods (68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT, MRI) in the same patient. Receives: Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring Tumour to Background Ratio
Measured: 4 years
Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.
Measured: 4 years
Secondary outcomes (5)
Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT
Measured: 4 years
Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT, 111 In-DOTA-exendin-4 SPECT/CT and standardized MRI in comparison with conventional imaging (CT,MRI and EUS)
Measured: 4 years
Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4
Through measurement of blood glucose and Quantification of Nausea respectively vomiting by means of the common toxicity criteria score system
Measured: 4 years
Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT
Measured: 4 years
Comparison of the angiogenesis markers with the those of breast carcinoma patients
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2014 (estimated)
- Study start6 Jan 2014
- Primary completionNov 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Endogenous Hyperinsulinaemic HypoglycaemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Desirée and Niels Yde's Foundation, Zürich, Switzerland
- Responsible party
- Sponsor
- Investigators
- Damian Wild, MD, PhD, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02127541
- Sponsor's protocol ID
- EKBB 163/12
- Status last verified
- Apr 2018
- First submitted
- 10 Feb 2014
- Last updated
- 18 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wild D, Macke H, Christ E, Gloor B, Reubi JC. Glucagon-like peptide 1-receptor scans to localize occult insulinomas. N Engl J Med. 2008 Aug 14;359(7):766-8. doi: 10.1056/NEJMc0802045. No abstract available.
PubMed 18703486Christ E, Wild D, Forrer F, Brandle M, Sahli R, Clerici T, Gloor B, Martius F, Maecke H, Reubi JC. Glucagon-like peptide-1 receptor imaging for localization of insulinomas. J Clin Endocrinol Metab. 2009 Nov;94(11):4398-405. doi: 10.1210/jc.2009-1082. Epub 2009 Oct 9.
PubMed 19820010Pattou F, Kerr-Conte J, Wild D. GLP-1-receptor scanning for imaging of human beta cells transplanted in muscle. N Engl J Med. 2010 Sep 23;363(13):1289-90. doi: 10.1056/NEJMc1004547. No abstract available.
PubMed 20860517Christ E, Wild D, Ederer S, Behe M, Nicolas G, Caplin ME, Brandle M, Clerici T, Fischli S, Stettler C, Ell PJ, Seufert J, Gloor B, Perren A, Reubi JC, Forrer F. Glucagon-like peptide-1 receptor imaging for the localisation of insulinomas: a prospective multicentre imaging study. Lancet Diabetes Endocrinol. 2013 Oct;1(2):115-22. doi: 10.1016/S2213-8587(13)70049-4. Epub 2013 Jul 25.
PubMed 24622317Antwi K, Nicolas G, Fani M, Heye T, Pattou F, Grossman A, Chanson P, Reubi JC, Perren A, Gloor B, Vogt DR, Wild D, Christ E. 68Ga-Exendin-4 PET/CT Detects Insulinomas in Patients With Endogenous Hyperinsulinemic Hypoglycemia in MEN-1. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5843-5852. doi: 10.1210/jc.2018-02754.
PubMed 31298706Valente LG, Antwi K, Nicolas GP, Wild D, Christ E. Clinical presentation of 54 patients with endogenous hyperinsulinaemic hypoglycaemia: a neurological chameleon (observational study). Swiss Med Wkly. 2018 Nov 18;148:w14682. doi: 10.4414/smw.2018.14682. eCollection 2018 Nov 5.
PubMed 30449018Antwi K, Fani M, Heye T, Nicolas G, Rottenburger C, Kaul F, Merkle E, Zech CJ, Boll D, Vogt DR, Gloor B, Christ E, Wild D. Comparison of glucagon-like peptide-1 receptor (GLP-1R) PET/CT, SPECT/CT and 3T MRI for the localisation of occult insulinomas: evaluation of diagnostic accuracy in a prospective crossover imaging study. Eur J Nucl Med Mol Imaging. 2018 Dec;45(13):2318-2327. doi: 10.1007/s00259-018-4101-5. Epub 2018 Jul 28.
PubMed 30054698
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Imaging Procedure for the Localisation of Insulinoma
- ClinicalTrials.gov ID
- NCT02127541
- Acronym / sponsor ID
- EKBB 163/12
- Keywords
- Localisation of Insulinoma, beta-cell imaging, exendin-4, 68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Insel Gruppe AG, University Hospital Bern, Desirée and Niels Yde's Foundation, Zürich, Switzerland
- Study start
- 6 Jan 2014
- Primary completion
- Nov 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 30 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Insulinoma: Insulinoma are rare, small insulin secreting neuroendocrine tumors. The only curative approach is the surgical excision. The preoperative detection remains a challenge. A non-invasive, highly sensitive tool in localizing the insulinomas would be appreciated in the preoperative work-up of these patients. To this aim Glucagon-like peptide-1 receptor (GLP-1R) imaging (Single Photon Emission Computer Tomography co-registered with a CT; SPECT/CT) could be a convenient tool. The possibly more sensitive approach of targeting GLP-1R using Positron emission tomography (PET/CT) methodology has not been investigated in patients so far.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ga -exendin PET/CT, In- exendin SPECT/CT, MRI | Experimental | Other: Ga -exendin PET/CT, In- exendin SPECT/CT, MRIThis is a cross-over study comparing three imaging methods (68Ga-DOTA-exendin-4 PET/CT, 111In-DOTA-exendin-4 SPECT/CT, MRI) in the same patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Biochemically proven endogenous hyperinsulinaemic hypoglycaemia in the fasting state with neuroglycopenic symptoms or autologous Islet Cell transplantation in the forearm
- Conventional imaging (CT,MRI or EUS) not older than 2 months
- Signed written consent
- Age above 18 years
Key exclusion criteria (6 listed)
- Kidney failure (creatinine > 140micromol/l)
- Known allergies against Exendin-4 (Byetta or Bydureon)
- Pregnancy
- Breastfeeding
- Medication with Byetta or Bydureon
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ga -exendin PET/CT, In- exendin SPECT/CT, MRIAlso: 68Ga-DOTA-exendin-4, 111In-DOTA-exendin-4, MRIComparison of different imaging modalities | Other | Ga -exendin PET/CT, In- exendin SPECT/CT, MRI |
Primary outcome
Measuring Tumour to Background Ratio
Time frame: 4 years
Measuring the accuracy of the Tumour-Localisation of 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT.
Time frame: 4 years
5 secondary outcomes
Accuracy of tumour localisation of standardized MRI in comparison with 68-DOTA-Exendin-4 PET/CT and 111 In-DOTA-exendin-4 SPECT/CT
Time frame: 4 years
Sensitivity of tumour localisation with 68-DOTA-Exendin-4 PET/CT, 111 In-DOTA-exendin-4 SPECT/CT and standardized MRI in comparison with conventional imaging (CT,MRI and EUS)
Time frame: 4 years
Evaluation of the side effects of 68Ga-DOTA-exendin-4 and 111In-DOTA-exendin-4
Time frame: 4 years
Evaluation of the interobserver variability of 68Ga-DOTA-Exendin-4 PET/CT and 111In-DOTA-exendin-4 SPECT/CT
Time frame: 4 years
Comparison of the angiogenesis markers with the those of breast carcinoma patients
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2018.
- Background: PubMed 18703486Wild D, Macke H, Christ E, Gloor B, Reubi JC. Glucagon-like peptide 1-receptor scans to localize occult insulinomas. N Engl J Med. 2008 Aug 14;359(7):766-8. doi: 10.1056/NEJMc0802045. No abstract available.
- Background: PubMed 19820010Christ E, Wild D, Forrer F, Brandle M, Sahli R, Clerici T, Gloor B, Martius F, Maecke H, Reubi JC. Glucagon-like peptide-1 receptor imaging for localization of insulinomas. J Clin Endocrinol Metab. 2009 Nov;94(11):4398-405. doi: 10.1210/jc.2009-1082. Epub 2009 Oct 9.
- Background: PubMed 20860517Pattou F, Kerr-Conte J, Wild D. GLP-1-receptor scanning for imaging of human beta cells transplanted in muscle. N Engl J Med. 2010 Sep 23;363(13):1289-90. doi: 10.1056/NEJMc1004547. No abstract available.
- Background: PubMed 24622317Christ E, Wild D, Ederer S, Behe M, Nicolas G, Caplin ME, Brandle M, Clerici T, Fischli S, Stettler C, Ell PJ, Seufert J, Gloor B, Perren A, Reubi JC, Forrer F. Glucagon-like peptide-1 receptor imaging for the localisation of insulinomas: a prospective multicentre imaging study. Lancet Diabetes Endocrinol. 2013 Oct;1(2):115-22. doi: 10.1016/S2213-8587(13)70049-4. Epub 2013 Jul 25.
- Derived from this study: PubMed 31298706Antwi K, Nicolas G, Fani M, Heye T, Pattou F, Grossman A, Chanson P, Reubi JC, Perren A, Gloor B, Vogt DR, Wild D, Christ E. 68Ga-Exendin-4 PET/CT Detects Insulinomas in Patients With Endogenous Hyperinsulinemic Hypoglycemia in MEN-1. J Clin Endocrinol Metab. 2019 Dec 1;104(12):5843-5852. doi: 10.1210/jc.2018-02754.
- Derived from this study: PubMed 30449018Valente LG, Antwi K, Nicolas GP, Wild D, Christ E. Clinical presentation of 54 patients with endogenous hyperinsulinaemic hypoglycaemia: a neurological chameleon (observational study). Swiss Med Wkly. 2018 Nov 18;148:w14682. doi: 10.4414/smw.2018.14682. eCollection 2018 Nov 5.
- Derived from this study: PubMed 30054698Antwi K, Fani M, Heye T, Nicolas G, Rottenburger C, Kaul F, Merkle E, Zech CJ, Boll D, Vogt DR, Gloor B, Christ E, Wild D. Comparison of glucagon-like peptide-1 receptor (GLP-1R) PET/CT, SPECT/CT and 3T MRI for the localisation of occult insulinomas: evaluation of diagnostic accuracy in a prospective crossover imaging study. Eur J Nucl Med Mol Imaging. 2018 Dec;45(13):2318-2327. doi: 10.1007/s00259-018-4101-5. Epub 2018 Jul 28.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Damian Wild, MD, PhD principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ga -exendin PET/CT, In- exendin SPECT/CT, MRI in people with Endogenous Hyperinsulinaemic Hypoglycaemia, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Tumour to Background Ratio (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02127541, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2018.