An Exploratory Study of 68Ga-DOTA-SEMA in Preoperative Precise Imaging of Patients with Glucagon-Like Peptide-1 Receptor (GLP1R) Positive Insulinomas

Traditional imaging techniques for insulinomas have a low detection rate. This study aims to evaluate the safety, internal radiation dosimetry, and targeted imaging capability of the novel GLP1R imaging agent, 68Ga-DOTA-SEMA, in patients with GLP1R-positive insulinomas.

Study Overview

• Status: Withdrawn
• Conditions: Hypoglycaemia
• Intervention / Treatment: Radiation: 68Ga-DOTA-SEMA

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Luzhou, Sichuan, China, 64600
      • The Affiliated Hospital of Southwest Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
2. Age ≥ 18 years.
3. Normal renal function (serum creatinine ≤ 1.5×ULN or creatinine clearance ≥ 50 mL/min, and estimated glomerular filtration rate (eGFR) > 80 mL/min/1.73 m²).
4. Recurrent hypoglycemia with biochemically confirmed endogenous hyperinsulinemic hypoglycemia (at least 3 episodes of biochemically confirmed endogenous hyperinsulinemic hypoglycemia within the past 3 months, each with detailed blood glucose monitoring records and symptom descriptions confirming endogenous hyperinsulinemia as the cause).
5. Negative for sulfonylurea drugs and insulin autoantibodies.
6. ECOG performance status ≤ 2, able to tolerate the examination.
7. All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.

Exclusion Criteria:

1. History of allergy or hypersensitivity to the components or excipients of the investigational drug.
2. Claustrophobia or inability to tolerate imaging procedures for other reasons.
3. Clinically significant active infection as determined by the investigator.
4. History or current presence of uncontrolled primary or metastatic brain tumors.

5. Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:

   1. Poorly controlled diabetes.
   2. Congestive heart failure.
   3. Myocardial infarction within the past 12 months.
   4. Uncontrolled and unstable hypertension.
   5. Chronic kidney disease or liver disease.
   6. Severe pulmonary diseases.
6. Poor compliance and inability to complete study procedures as expected.
7. Any other conditions that the investigator considers unsuitable for participation in the clinical study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group	Radiation: 68Ga-DOTA-SEMA; 68Ga-DOTA-SEMA is GLP1R imaging agent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Radiation dose to major organs and tumors	7 days

Collaborators and Investigators

• Sponsor: The Affiliated Hospital Of Southwest Medical University

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 28, 2024
• First Submitted That Met QC Criteria: December 28, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 12, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Metabolic Diseases; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Glucose Metabolism Disorders; Endocrine Gland Neoplasms; Pancreatic Diseases; Neoplasms, Glandular and Epithelial; Adenoma; Pancreatic Neoplasms; Adenoma, Islet Cell; Hypoglycemia; Insulinoma
• Other Study ID Numbers: AHSWMU-2024-072

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No