Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma
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ClinicalTrials.gov Identifier: NCT04185350 |
Recruitment Status : Unknown
Verified December 2019 by FengWang, Nanjing First Hospital, Nanjing Medical University.
Recruitment status was: Recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
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Condition or disease | Intervention/treatment | Phase |
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Insulinoma | Drug: 68Ga-NOTA-MAL-Cys39-exendin-4 | Early Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Clinical Evaluation of 68Ga-NOTA-MAL-Cys39-exendin-4 Positron Emission Tomography in the Detection of Insulinoma |
Actual Study Start Date : | May 5, 2019 |
Estimated Primary Completion Date : | April 5, 2020 |
Estimated Study Completion Date : | May 5, 2020 |

Arm | Intervention/treatment |
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Experimental: 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT
The patients were injected with 111-185 MBq of 68Ga-NOTA-MAL-Cys39-exendin-4 PET/CT in one dose intravenously and underwent PET/CT scan 60 min later.
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Drug: 68Ga-NOTA-MAL-Cys39-exendin-4
After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans. |
- Standardized uptake value [ Time Frame: 1 year ]Calculation of the standardized uptake value 68Ga-NOTA-MAL-Cys39-exendin-4 in Diagnosis of Insulinoma
- GLP-1 receptor expression by histology compared to tracer uptake [ Time Frame: 1 year ]Pathological detection of GLP-1 receptor expression in patients' lesions and compared to tracer uptake by PET/CT
- Incidence of Adverse Events [ Time Frame: Adverse events within 1 week after the injection and scanning of patients will be followed and assessed ]This study will utilize the CTCAE (NCI Common Terminology Criteria for Adverse Events) Version 4.0 for toxicity and Serious Adverse Event reporting

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- The patient volunteers and signs an informed consent form.
- age ≥18 and ≤75 years old;
- 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 3 month.
Exclusion Criteria:
- Having a history of allergy to similar drugs, allergic constitution or suffering from allergic diseases;
- Breast feeding;
- Pregnancy or the wish to become pregnant within 6 months;
- Renal function: serum creatinine > 3.0 mg/dl;
- Any medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.

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): NCT04185350
Contact: Feng Wang, Ph.D | +8602552271491 | fengwangcn@hotmail.com |
China, Jiangsu | |
Nanjing First Hospital | Recruiting |
Nanjing, Jiangsu, China, 210006 | |
Contact: Pengjun Zhang, M.S +8602552271456 pengjunmr@163.com |
Study Director: | Feng Wang, Ph.D | The First Affiliated Hospital with Nanjing Medical University |
Responsible Party: | FengWang, Director of Nuclear Medicine, Nanjing First Hospital, Nanjing Medical University |
ClinicalTrials.gov Identifier: | NCT04185350 |
Other Study ID Numbers: |
NJCNMC-GLP-1 |
First Posted: | December 4, 2019 Key Record Dates |
Last Update Posted: | December 4, 2019 |
Last Verified: | December 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Insulinoma 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 Exenatide Hypoglycemic Agents Physiological Effects of Drugs Anti-Obesity Agents Incretins Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |