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NCT03511768 Clinical Trial

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

Neuroendocrine Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03511768
Other study ID # 201801001
Secondary ID
Status Recruiting
Phase Phase 1/Phase 2
First received
Last updated
Start date January 2, 2018
Est. completion date December 30, 2020

Study information
Verified date April 2018
Source Xiangya Hospital of Central South University
Contact Tingting Long, MD,Phd
Phone +86 13549682646
Email longtingting@csu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 65
Est. completion date December 30, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• 18F-AlF-NOTA-octreotide
One injection of 18F-AlF-NOTA-octreotide
Device:
• PET/CT
Following injection of 18F-AlF-NOTA-octreotide the participants will be subjected to whole body PET/CT

Locations
Country Name City State
China Department of PET Center,Xiangya Hospital,Central South University Changsha Hunan

Sponsors (1)
Lead Sponsor Collaborator
Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 12 months
Secondary 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 24 months
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