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A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms

Primary Purpose

Neuroendocrine Neoplasm

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
18F-AlF-NOTA-octreotide
PET/CT
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neuroendocrine Neoplasm focused on measuring 18F-AlF-NOTA-octreotide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Histologically and/or clinically confirmed and/or suspicious of NEN.
  2. Signed informed consent.

Exclusion Criteria:

  1. Claustrophobia (unable to accept PET/CT scanning)
  2. Pregnant or breast-feeding

Sites / Locations

  • Department of PET Center,Xiangya Hospital,Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-AlF-NOTA-octreotide PET/CT

Arm Description

One injection of the radioligand 18F-AlF-NOTA-octreotide

Outcomes

Primary Outcome Measures

18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms

Secondary Outcome Measures

18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival
The uptake of the 18F-AlF-NOTA-octreotide in neuroendocrine neoplasm lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine neoplasms

Full Information

First Posted
April 17, 2018
Last Updated
April 17, 2018
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT03511768
Brief Title
A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Official Title
A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2018 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to investigate the clinical value of [18F]aluminum fluoride-1,4,7-triazacyclononane-1,4,7-triacetic acid-octreotide（18F-AlF-NOTA-octreotide ） positron emission tomography / computed tomography (PET/CT) in patients with neuroendocrine neoplasms (NENs).
Detailed Description
18F-AlF-NOTA-octreotide is a radioligand targeting the somatostatin receptor, which is widely expressed on the cell surface of NENs. The radioligand can be used for the diagnosis and stage of the NENs. A total of 5 volunteers and 60 NEN patients will be subjected to a 18F-AlF-NOTA-octreotide PET/CT scan. The uptake of 18F-AlF-NOTA-octreotide in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroendocrine Neoplasm
Keywords
18F-AlF-NOTA-octreotide

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
18F-AlF-NOTA-octreotide PET/CT
Arm Type
Experimental
Arm Description
One injection of the radioligand 18F-AlF-NOTA-octreotide
Intervention Type
Drug
Intervention Name(s)
18F-AlF-NOTA-octreotide
Other Intervention Name(s)
18F-IMP466
Intervention Description
One injection of 18F-AlF-NOTA-octreotide
Intervention Type
Device
Intervention Name(s)
PET/CT
Intervention Description
Following injection of 18F-AlF-NOTA-octreotide the participants will be subjected to whole body PET/CT
Primary Outcome Measure Information:
Title
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms
Description
The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms
Time Frame
12 months
Secondary Outcome Measure Information:
Title
18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival
Description
The uptake of the 18F-AlF-NOTA-octreotide in neuroendocrine neoplasm lesions (quantified as Standard Uptake Values) is associated with overall and disease specific free survival (PFS) neuroendocrine neoplasms
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically and/or clinically confirmed and/or suspicious of NEN. Signed informed consent. Exclusion Criteria: Claustrophobia (unable to accept PET/CT scanning) Pregnant or breast-feeding
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tingting Long, MD,Phd
Phone
+86 13549682646
Email
longtingting@csu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Shuo Hu, professor
Phone
+86 15874210819
Email
hushuo_xy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tingting Long, MD,Phd
Organizational Affiliation
Department of PET Center,Xiangya Hospital, Central South University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of PET Center,Xiangya Hospital,Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tingting Long, MD,Phd
Phone
+86 13549682646
Email
longtingting@csu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20150268
Citation
Laverman P, McBride WJ, Sharkey RM, Eek A, Joosten L, Oyen WJ, Goldenberg DM, Boerman OC. A novel facile method of labeling octreotide with (18)F-fluorine. J Nucl Med. 2010 Mar;51(3):454-61. doi: 10.2967/jnumed.109.066902. Epub 2010 Feb 11.
Results Reference
result

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A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms

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