Current partner codePEPTIDESDE
NCT06725693·Not applicable·OBSERVATIONAL

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

Status

Recruiting

Phase

Not applicable

Enrollment

500

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

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.

Full detailed description

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.

Interventions

Treatment arms and agents.

DIAGNOSTIC_TEST

18F/68Ga-Exendin 4

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

Timeline

From registration to results.

  1. First posted

    Dec 10, 2024

  2. Study start

    Feb 1, 2019

  3. Primary completion

    Nov 1, 2027

  4. Study completion

    Nov 1, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Feb 11, 2025

Outcomes

What the study measures.

Primary outcomes

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

Diagnostic efficacy

Time frame · 30 days

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
Yes

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.

Study locations

1 registered sites.

China. Showing up to 24 locations stored in the fast local snapshot.

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.