Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
Primary Purpose
Neuroendocrine Tumor
Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Al18F-octreotide
Sponsored by
About this trial
This is an interventional diagnostic trial for Neuroendocrine Tumor
Eligibility Criteria
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.
Sites / Locations
- National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Al18F-octreotide PET/CT
Arm Description
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.
Outcomes
Primary Outcome Measures
Diagnostic value
Sensitivity and Specificity of Al18F-octreotide PET/CT for Neuroendocrine Tumor
Secondary Outcome Measures
Full Information
NCT ID
NCT05749289
First Posted
February 19, 2023
Last Updated
February 19, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT05749289
Brief Title
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
Official Title
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 20, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
December 20, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Tumor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Al18F-octreotide PET/CT
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Al18F-octreotide
Other Intervention Name(s)
Al18F-NOTA-TATE
Intervention Description
Al18F-octreotide I was injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Diagnostic value
Description
Sensitivity and Specificity of Al18F-octreotide PET/CT for Neuroendocrine Tumor
Time Frame
through study completion, an average of 1 year]
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gouzhu Hou, M.D.
Phone
15611145656
Email
15611145656@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Cheng, M.D.
Phone
15120002998
Email
cxpumc@foxmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rong Zheng, M.D.
Organizational Affiliation
National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and PUMC
Official's Role
Study Director
Facility Information:
Facility Name
National Cancer Center/Cancer Hospital,Chinese Academy of Medical Sciences and Peking Union Medical College
City
Beijing
State/Province
Chao Yang
ZIP/Postal Code
100021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhu Hou, M.D.
Phone
15611145656
Email
15611145656@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Application of Al18F-octreotide PET/CT in Neuroendocrine Tumor
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