Current partner codePEPTIDESDE
NCT05034783·Early Phase 1·INTERVENTIONAL

[68Ga]Ga-HBED-CC-exendin-4 and [68Ga]Ga-NOTA-exendin-4 PET/CT Imaging in the Same Group of Insulinoma Patients

Status

Unknown

Phase

Early Phase 1

Enrollment

20

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

Glucagon-like peptide-1 receptor (GLP-1R)-targeted PET imaging with 68Ga-labeled compounds is able to provide superior sensitivity and specificity to detect insulinoma, like the widely studied \[68Ga\]Ga-NOTA-exendin-4. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, which was compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.

Full detailed description

Insulinoma is the most common cause of endogenous hyperinsulinemic hypoglycemia in adult patients without diabetes. The only curative treatment of an insulinoma is its surgical removal. Therefore, exact preoperative localization of the insulinoma is critical to planning the surgical intervention. MR imaging, CT, or endoscopic ultrasound is normally used to localize insulinomas. However, the small size of the tumors (often,1 cm) limits the sensitivity of these methods. In recent years, a new receptor-targeted imaging technique, glucagon-like peptide-1 receptor (GLP-1R) imaging, for detecting insulinoma has been established. GLP-1R is expressed on benign insulinoma cell surfaces with very high incidence (\>90%) and density (8,133 dpm/mg of tissue). No other peptide receptor has been found to exhibit such high expression levels in insulinoma. \[68Ga\]Ga-HBED-CC-exendin-4, a novel radiopharmaceutical targeting GLP-1R, with the urea fragment of a conjugate that employs the HBED-CC chelator for labeling with 68Ga in order to In order to reduce the accumulation of radioactivity in the kidneys. This pilot study was prospectively designed to evaluate the early dynamic distribution of \[68Ga\]Ga-HBED-CC-exendin-4 compared with \[68Ga\]Ga-NOTA-exendin-4 in the same group of Insulinoma patients.

Interventions

Treatment arms and agents.

DRUG

[68Ga]Ga-HBED-CC-exendin-4

Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) \[68Ga\]Ga-HBED-CC-exendin-4. Tracer doses of \[68Ga\]Ga-HBED-CC-exendin-4 will be used to image lesions of insulinoma by PET/CT.

DRUG

[68Ga]Ga-NOTA-exendin-4

Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) \[68Ga\]Ga-NOTA-exendin-4. Tracer doses of \[68Ga\]Ga-NOTA-exendin-4 will be used to image lesions of insulinoma by PET/CT.

Timeline

From registration to results.

  1. First posted

    Sep 5, 2021

  2. Study start

    Oct 1, 2021

  3. Primary completion

    Oct 13, 2022

  4. Study completion

    Jun 1, 2023

  5. Results posted

    Not reported

  6. Registry updated

    Oct 14, 2022

Outcomes

What the study measures.

Primary outcomes

Metabolic parameters

Time frame · through study completion, an average of 1 year

the early dynamic distribution (SUVmax in tumor lesions and SUVmean in normal organs at different time points) of \[68Ga\]Ga-HBED-CC-exendin-4 in comparison with \[68Ga\]Ga-NOTA-exendin-4 in the same group of insulinoma patients.

Secondary outcomes

Diagnostic value

Time frame · through study completion, an average of 1 year

Sensitivity and Specificity of \[68Ga\]Ga-HBED-CC-exendin-4 for insulinoma in comparison with \[68Ga\]Ga-NOTA-exendin-4 PET/CT.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
80 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * confirmed treated or untreated insulinoma patients; * \[68Ga\]Ga-HBED-CC-exendin-4 and \[68Ga\]Ga-NOTA-exendin-4 PET/CT within two consecutive days; * signed written consent. Exclusion Criteria: * pregnancy; * breastfeeding; * known allergy against exendin-4; * any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Study locations

1 registered sites.

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

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Related trials

More studies on Exenatide.

Related PeptideStat pages

Put the record in context.

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