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

NCT ID: NCT03511768

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-02

Study Completion Date

2020-12-30

Brief Summary

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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

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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).

Conditions

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Neuroendocrine Neoplasm

Keywords

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18F-AlF-NOTA-octreotide

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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18F-AlF-NOTA-octreotide PET/CT

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

Group Type EXPERIMENTAL

18F-AlF-NOTA-octreotide

Intervention Type DRUG

One injection of 18F-AlF-NOTA-octreotide

PET/CT

Intervention Type DEVICE

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

Interventions

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18F-AlF-NOTA-octreotide

One injection of 18F-AlF-NOTA-octreotide

Intervention Type DRUG

PET/CT

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

Intervention Type DEVICE

Other Intervention Names

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18F-IMP466

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Xiangya Hospital of Central South University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tingting Long, MD,Phd

Role: PRINCIPAL_INVESTIGATOR

Department of PET Center,Xiangya Hospital, Central South University

Locations

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Department of PET Center,Xiangya Hospital,Central South University

Changsha, Hunan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tingting Long, MD,Phd

Role: CONTACT

Phone: +86 13549682646

Email: [email protected]

Shuo Hu, professor

Role: CONTACT

Phone: +86 15874210819

Email: [email protected]

Facility Contacts

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Tingting Long, MD,Phd

Role: primary

References

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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.

Reference Type RESULT
PMID: 20150268 (View on PubMed)

Other Identifiers

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201801001

Identifier Type: -

Identifier Source: org_study_id