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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05749289
Other study ID # NCC 3744
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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]
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