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

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

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03511768
Enrollment
65
Registered
2018-04-30
Start date
2018-01-02
Completion date
2020-12-30
Last updated
2018-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroendocrine Neoplasm

Keywords

18F-AlF-NOTA-octreotide

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).

Interventions

DRUG18F-AlF-NOTA-octreotide

One injection of 18F-AlF-NOTA-octreotide

DEVICEPET/CT

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

Sponsors

Xiangya Hospital of Central South University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms12 monthsThe radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms

Secondary

MeasureTime frameDescription
18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival24 monthsThe 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

Countries

China

Contacts

Primary ContactTingting Long, MD,Phd
longtingting@csu.edu.cn+86 13549682646
Backup ContactShuo Hu, professor
hushuo_xy@163.com+86 15874210819

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026