Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

Phase 2

Recruiting

• Conditions: Neuroendocrine Tumor
• Interventions: Drug: Al18F-octreotide

• Registration Number: NCT05749289
• Lead Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Brief Summary

This is an open-label whole-body PET/CT study for investigating the value of Al18F-octreotide PET/CT in patients with Neuroendocrine Tumor

Detailed Description

Octreotide is an artificial replacement for the natural growth hormone inhibitor in humans. It is a small peptide hormone consisting of 14 amino acids and is widely distributed in neuroendocrine cells, with the highest density in the brain, peripheral neurons, endocrine pancreas and gastrointestinal tract. Under pathological conditions, some tumour cells show overexpression of growth inhibitory receptors, such as endocrine tumours of the pancreas, pituitary adenomas, pheochromocytomas, paragangliomas, carcinoid tumours, medullary thyroid carcinomas, small cell lung carcinomas and other neuroendocrine tumours. Therefore, the sensitivity and specificity of octreotide imaging is high.

This study will provide a visual, reproducible and non-invasive imaging method for the diagnosis of neuroendocrine tumours through Al18F-octreotide PCT/CT imaging, providing an intuitive and clear imaging basis for clinical diagnosis, differential diagnosis and treatment, contributing to the development of medicine and science in the field of positron imaging.

Study Timeline

• Study Start: 2022-12-20
• Study First Submitted: 2023-02-19
• Study First Submitted QC: 2023-02-19
• Study First Posted: 2023-03-01
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-03-29
• Primary Completion: 2024-12-20
• Study Completion: 2025-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with suspected or clearly diagnosed Neuroendocrine Tumor
• signed written consent.
• Willing and able to cooperate with all projects in this study.

Exclusion Criteria

• pregnancy;
• breastfeeding;
• any medical condition that in the opinion of the investigator may significantly interfere with study compliance.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Al18F-octreotide PET/CT	Al18F-octreotide	Al18F-octreotide PET/CT will be performed on patients with suspected or clearly diagnosed Neuroendocrine Tumor. The patients were injected with Al18F-octreotide and underwent PET/CT scan 20\~40min after the injection.

Primary Outcome Measures

Name	Time	Method
Diagnostic value	through study completion, an average of 1 year]	Sensitivity and Specificity of Al18F-octreotide PET/CT for Neuroendocrine Tumor

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College; 🇨🇳 Beijing, Chao Yang, China