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

Central South University

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Neuroendocrine Neoplasm

Treatments: Drug: 18F-AlF-NOTA-octreotide; Device: PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03511768

201801001

Details and patient eligibility

About

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).

Full 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).

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

18F-AlF-NOTA-octreotide PET/CT

Experimental group

Description:

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

Treatment:

Device: PET/CT

Drug: 18F-AlF-NOTA-octreotide