Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

Neuroendocrine Tumor Clinical Trial

Official title:

Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05749289
• Other study ID #: NCC 3744
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: December 20, 2022
• Est. completion date: December 20, 2025

Study information

• Verified date: March 2024
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Gouzhu Hou, M.D.
• Phone: 15611145656
• Email: 15611145656[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 20, 2025
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuroendocrine Tumor
• Neuroendocrine Tumors

Intervention

Drug:
• Al18F-octreotide
Al18F-octreotide I was injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College	Beijing	Chao Yang

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic value	Sensitivity and Specificity of Al18F-octreotide PET/CT for Neuroendocrine Tumor	through study completion, an average of 1 year]