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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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
February 19, 2023
Last Updated
February 19, 2023
Sponsor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
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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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