Using a special imaging technique to detect insulinomas
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma
This study is testing a new imaging method to see if it can better find insulinomas in patients who have low blood sugar due to these tumors.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Years to 70 Years |
| Sex | All |
| Sponsor | First Affiliated Hospital of Fujian Medical University Academic / other |
| Locations | 1 site (Fuzhou, Fujian) |
| Trial ID | NCT04979611 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of 68Ga-NOTA-exendin-4 PET/CT imaging in detecting insulinomas, which are small tumors that can cause hypoglycemia. Patients diagnosed with endogenous hyperinsulinemic hypoglycemia will receive an intravenous injection of 68Ga-NOTA-exendin-4, and the resulting PET/CT images will be assessed using visual and semiquantitative methods. The study aims to compare the diagnostic value of this imaging technique against traditional CT and MRI methods.
Who should consider this trial
Good fit: Ideal candidates include patients aged 6 years and older who have been diagnosed with endogenous hyperinsulinemic hypoglycemia and have undergone enhanced CT or MRI within the last month.
Not a fit: Patients who are pregnant, breastfeeding, or have certain medical conditions that may interfere with study compliance will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more accurate diagnostic tool for detecting insulinomas, leading to better management of patients with hypoglycemia.
How similar studies have performed: While the use of GLP-1R targeting probes is emerging, this specific application of 68Ga-NOTA-exendin-4 PET/CT for insulinoma detection is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent Exclusion Criteria: * 1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy
Where this trial is running
Fuzhou, Fujian
- Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujian, China (Recruiting)
Study contacts
- Study coordinator: weibing miao, MD
- Email: miaoweibing@126.com
- Phone: 86-0591-87981618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.