Clinical Trial Record

Return to Clinical Trials

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


2026-01


2026-12


2026-12


0

Study Overview

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.

N/A

  • Hypoglycaemia
  • RADIATION: 68Ga-DOTA-SEMA
  • AHSWMU-2024-072

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2024-12-28  

N/A  

2025-03-12  

2024-12-28  

N/A  

2025-03-25  

2025-03-25  

N/A  

2024-12  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Diagnostic


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Experimental group

RADIATION: 68Ga-DOTA-SEMA

  • 68Ga-DOTA-SEMA is GLP1R imaging agent
Primary Outcome MeasuresMeasure DescriptionTime Frame
Radiation dose to major organs and tumors7 days
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available