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

NCT06759740 | Withdrawn

• 1 other identifier: AHSWMU-2024-072
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoglycaemia

Outcome Measures

Primary Outcomes (1)

• Radiation dose to major organs and tumors

  7 days

Study Arms (1)

Experimental group

EXPERIMENTAL

Radiation: 68Ga-DOTA-SEMA

Interventions

68Ga-DOTA-SEMA RADIATION

68Ga-DOTA-SEMA is GLP1R imaging agent

Experimental group

Eligibility Criteria

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

You may qualify if:

• Patients who are capable of understanding and voluntarily signing an approved informed consent form (ICF).
• Age ≥ 18 years.
• 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).
• 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).
• Negative for sulfonylurea drugs and insulin autoantibodies.
• ECOG performance status ≤ 2, able to tolerate the examination.
• All other toxicities must be ≤ NCI-CTCAE v5.0 Grade 0 or 1.

You may not qualify if:

• History of allergy or hypersensitivity to the components or excipients of the investigational drug.
• Claustrophobia or inability to tolerate imaging procedures for other reasons.
• Clinically significant active infection as determined by the investigator.
• History or current presence of uncontrolled primary or metastatic brain tumors.
• Serious and/or uncontrolled and/or unstable conditions that may affect the study as judged by the investigator, including but not limited to:
• Poorly controlled diabetes.
• Congestive heart failure.
• Myocardial infarction within the past 12 months.
• Uncontrolled and unstable hypertension.
• Chronic kidney disease or liver disease.
• Severe pulmonary diseases.
• Poor compliance and inability to complete study procedures as expected.
• Any other conditions that the investigator considers unsuitable for participation in the clinical study.

Sponsors & Collaborators

• The Affiliated Hospital Of Southwest Medical University: lead

Study Sites (1)

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, 64600, China

Location

MeSH Terms

Conditions

Hypoglycemia

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 28, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 14, 2025

Record last verified: 2024-12

Locations

CN (1)