NCT03511768

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2018

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 30, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

2 years

First QC Date

April 17, 2018

Last Update Submit

April 17, 2018

Conditions

Neuroendocrine Neoplasm

Keywords

18F-AlF-NOTA-octreotide

Outcome Measures

Primary Outcomes (1)

  • 18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms

    The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms

    12 months

Secondary Outcomes (1)

  • 18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival

    24 months

Study Arms (1)

18F-AlF-NOTA-octreotide PET/CT

EXPERIMENTAL

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

Drug: 18F-AlF-NOTA-octreotideDevice: PET/CT

Interventions

18F-AlF-NOTA-octreotideDRUG

One injection of 18F-AlF-NOTA-octreotide

Also known as: 18F-IMP466
18F-AlF-NOTA-octreotide PET/CT
PET/CTDEVICE

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

18F-AlF-NOTA-octreotide PET/CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically and/or clinically confirmed and/or suspicious of NEN.
  • Signed informed consent.

You may not qualify if:

  • Claustrophobia (unable to accept PET/CT scanning)
  • Pregnant or breast-feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of PET Center,Xiangya Hospital,Central South University

Changsha, Hunan, 410008, China

RECRUITING

Related Publications (1)

  • 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.

    PMID: 20150268RESULT

MeSH Terms

Conditions

Neuroendocrine Tumors

Interventions

Al18F-NOTA-octreotidePositron Emission Tomography Computed Tomography

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Positron-Emission TomographyTomography, Emission-ComputedImage Interpretation, Computer-AssistedDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomography, X-Ray ComputedMultimodal ImagingRadiographic Image EnhancementImage EnhancementPhotographyRadiographyTomography, X-RayRadionuclide ImagingTomographyDiagnostic Techniques, Radioisotope

Study Officials

  • Tingting Long, MD,Phd

    Department of PET Center,Xiangya Hospital, Central South University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tingting Long, MD,Phd

CONTACT

+86 13549682646longtingting@csu.edu.cn

Shuo Hu, professor

CONTACT

+86 15874210819hushuo_xy@163.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2018

First Posted

April 30, 2018

Study Start

January 2, 2018

Primary Completion

December 30, 2019

Study Completion

December 30, 2020

Last Updated

April 30, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)