Phase 2 clinical trial of 18F-labeled exendin-4 for PET imaging of insulinoma

JRCT ID: jRCTs051200156

Registered date:17/03/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: insulinoma
• Date of first enrollment: 12/08/2022
• Target sample size: 20
• Study type: Interventional
• Intervention(s): PET scanning for insulinoma patients

Outcome(s)

• Primary Outcome: detection of tumor
• Secondary Outcome: Safety for insulinoma patients

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Clinically proven presence of an insulinoma
2) Written consent has been obtained from the subject for participation in this study (16 years and older).
In the case of a minor, consent has been obtained from the surrogate.

Exclude criteria

1) Patients have severe liver or kidney dysfunction
2) Inability to discontinue GLP-1 related products (requires discontinuation 3 weeks before testing)
3) Patients who are unsuitable or contraindicated for exenatide administration
4) Patients with alcohol intolerance
5) Pregnant or lactating women
6) Patients who judged to be inappropriate for enrolment by the physician

Related Information

• Primary Sponsor: Murakami Takaaki