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NCT Number: NCT06725693

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

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.

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Key information

Conditions

GLP1-R-related Disease Adenoma Adenoma, Islet Cell Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Insulinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pancreatic Diseases Pancreatic Neoplasms Positron Emission Tomography Tumor

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location status: Recruiting

Location contact

Haonan Yu, MD

CONTACT

[email protected]

+8613821000597

About this study

Subjects with various GLP1-R-related disease patients underwent 68Ga/18F-Exendin 4 PET/CT either for an initial assessment or for recurrence detection. Lesions uptake was quantified by the maximum standard uptake value (SUVmax). The sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 68Ga/18F-Exendin 4 PET/CT were calculated.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (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.

Exclusion criteria

  • (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.

Treatment and study plan

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.

Primary outcomes

  1. Standardized uptake value (SUV)

    Time frame: 30 days

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

Secondary outcomes

  1. Diagnostic efficacy

    Time frame: 30 days

    The sensitivity, specificity and accuracy of Exendin 4 PET/CT were calculated.

Study contacts

Contact information is provided by the study sponsor or research team.

Haonan Yu, MD

CONTACT

[email protected]

+8613821000597

Qiusong Chen, MD

CONTACT

[email protected]

+862260362190

Sponsors and collaborators

Lead sponsor

Tianjin Medical University

Other

Collaborators

  • Tianjin Medical University General Hospital

Registry information

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Feb 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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