A Study of 18F-AlF-NOTA-Neurotensin PET/CT for Imaging Prostate Cancer

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03516045

Enrollment

Registered

2018-05-04

Start date

2018-04-23

Completion date

2020-12-30

Last updated

2018-05-17

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

Conditions

Prostate Cancer

Keywords

18F-AlF-NOTA-neurotensin

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-neurotensin（18F-AlF-NOTA-neurotensin）positron emission tomography / computed tomography (PET/CT) in patients with prostate cancer (PCa).

Detailed description

18F-AlF-NOTA-neurotensin is a radioligand targeting the neurotensinreceptor, which is widely expressed on the cell surface of PCa. The radioligand can be used for the diagnosis and stage of the PCa. A total of 5 volunteers and 60 PCa patients will be subjected to a 18F-AlF-NOTA-neurotensin PET/CT scan. The uptake of 18F-AlF-NOTA-neurotensin in organs and tumor lesions will be quantified as Standardized Uptake Values (SUVmax/SUVmean).

Interventions

DRUG18F-AlF-NOTA-neurotensin

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

Study design

Allocation

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 PCa. 2. Signed informed consent.

Exclusion criteria

Claustrophobia (unable to accept PET/CT scanning)

Design outcomes

Primary

Measure	Time frame	Description
18F-AlF-NOTA-neurotensin PET/CT imaging of patients with Prostate Cancer	12 months	The radioligand 18F-AlF-NOTA-neurotensin can be used to visualize prostate cancer

Secondary

Measure	Time frame	Description
18F-AlF-NOTA-neurotensin PET/CT prognostic factor for overall and disease specific survival	24 months	The standard uptake value (SUV) of the 18F-AlF-NOTA-neurotensin in prostate cancer lesions is associated with Gleason score, staging and risk stratification of prostate cancer. SUV (g/mL)=Cimg / (ID/BW) ; Cimg is the prostate cancer pixel intensities of a calibrated PET image (MBq/ml), ID is the injected dose or injected radioactivity (MBq),BW is the body weight (g) . Gleason score of a prostate biopsy or radical prostatectomy.

Countries

China

Contacts

Primary ContactYongxiang Tang, MD

yxtang@csu.edu.cn+86 13549654360

Backup ContactShuo Hu, MD, Phd

hushuo_xy@163.com+86 15874210819

Outcome results

None listed

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