Glucagon-like Peptide-1 Receptor PET/CT in GLP-1R Related Disease

NCT06725693 | Recruiting

• 1 other identifier: TJMUGH-06
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the potential usefulness of 68Ga/18F-Exendin 4 positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and metastatic lesions in various GLP-1R-related disease patients.

Conditions

GLP1-R-related Disease; Tumor; Insulinoma; Positron Emission Tomography

Keywords

PET/CT; GLP1-R

Outcome Measures

Primary Outcomes (1)

• Standardized uptake value (SUV)

  Standardized uptake value (SUV) of Exendin 4 for each target lesion of subject or suspected primary tumor or/and metastasis

  30 days

Secondary Outcomes (1)

• Diagnostic efficacy

  30 days

Study Arms (1)

Single Group Assignment

Each subject receive a single intravenous injection of 68Ga/18F-Exendin 4, and undergo PET/CT imaging within the specificed time.

Diagnostic Test: 18F/68Ga-Exendin 4

Interventions

18F/68Ga-Exendin 4 DIAGNOSTIC_TEST

Each subject receive a single intravenous injection of 68Ga/18F-Exendin 4, and undergo PET/CT imaging within the specificed time.

Single Group Assignment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

(i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Exendin 4 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may qualify if:

• \- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Exendin 4 PET/CT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

• \- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Sponsors & Collaborators

• Tianjin Medical University: lead
• Tianjin Medical University General Hospital: collaborator

Study Sites (1)

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

RECRUITING

Related Publications (1)

• Yu H, Bao X, Gu Y, Pan M, He Q, Li D, Chen Q, Yao S. Comparison of PET/CT using 68Ga-NOTA-Exendin-4 with 68Ga-DOTATATE, 18F-FDG, and conventional imaging in the localization of insulinomas. Eur J Nucl Med Mol Imaging. 2025 Sep;52(11):4102-4111. doi: 10.1007/s00259-025-07288-x. Epub 2025 Apr 22.

  PMID: 40259061 DERIVED

MeSH Terms

Conditions

Neoplasms; Insulinoma

Condition Hierarchy (Ancestors)

Adenoma, Islet Cell; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Pancreatic Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Central Study Contacts

Qiusong Chen, MD

CONTACT

+862260362190; qs_c8@hotmail.com

Haonan Yu, MD

CONTACT

+8613821000597; dreamadam@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 7 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: February 1, 2019
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 11, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)