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

NCT ID: NCT06759740

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Experimental group

Group Type: EXPERIMENTAL

68Ga-DOTA-SEMA

Intervention Type: RADIATION

68Ga-DOTA-SEMA is GLP1R imaging agent

Interventions

68Ga-DOTA-SEMA

68Ga-DOTA-SEMA is GLP1R imaging agent

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Hospital Of Southwest Medical University

OTHER

Sponsor Role: lead

Responsible Party

Xie Yang

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Countries

China

Other Identifiers

AHSWMU-2024-072

Identifier Type: -

Identifier Source: org_study_id