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

Phase 1

• Conditions: Neuroendocrine Neoplasm
• Interventions: Drug: 18F-AlF-NOTA-octreotide; Device: PET/CT

• Registration Number: NCT03511768
• Lead Sponsor: Xiangya Hospital of Central South University

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).

Study Timeline

• Study Start: 2018-01-02
• Status Verified: 2018-04
• Study First Submitted: 2018-04-17
• Study First Submitted QC: 2018-04-17
• Last Update Submitted: 2018-04-17
• Study First Posted: 2018-04-30
• Last Update Posted: 2018-04-30
• Primary Completion: 2019-12-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 65

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
18F-AlF-NOTA-octreotide PET/CT	18F-AlF-NOTA-octreotide	One injection of the radioligand 18F-AlF-NOTA-octreotide
18F-AlF-NOTA-octreotide PET/CT	PET/CT	One injection of the radioligand 18F-AlF-NOTA-octreotide

Primary Outcome Measures

Name	Time	Method
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms	12 months	The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms

Secondary Outcome Measures

Name	Time	Method
18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival	24 months	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

Trial Locations

Locations (1)

Department of PET Center,Xiangya Hospital,Central South University; 🇨🇳 Changsha, Hunan, China