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

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ClinicalTrials.gov Identifier: NCT03511768
Recruitment Status : Recruiting
First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Xiangya Hospital of Central South University

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).

Condition or disease Intervention/treatment Phase
Neuroendocrine Neoplasm Drug: 18F-AlF-NOTA-octreotide Device: PET/CT Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Actual Study Start Date : January 2, 2018
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2020


Arm Intervention/treatment
Experimental: 18F-AlF-NOTA-octreotide PET/CT
One injection of the radioligand 18F-AlF-NOTA-octreotide
Drug: 18F-AlF-NOTA-octreotide
One injection of 18F-AlF-NOTA-octreotide
Other Name: 18F-IMP466

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




Primary Outcome Measures :
  1. 18F-AlF-NOTA-octreotide PET/CT imaging of patients with Neuroendocrine Neoplasms [ Time Frame: 12 months ]
    The radioligand 18F-AlF-NOTA-octreotide can be used to visualize neuroendocrine neoplasms


Secondary Outcome Measures :
  1. 18F-AlF-NOTA-octreotide PET/CT prognostic factor for overall and disease specific survival [ Time Frame: 24 months ]
    The 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03511768


Contacts
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Contact: Tingting Long, MD,Phd +86 13549682646 longtingting@csu.edu.cn
Contact: Shuo Hu, professor +86 15874210819 hushuo_xy@163.com

Locations
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China, Hunan
Department of PET Center,Xiangya Hospital,Central South University Recruiting
Changsha, Hunan, China, 410008
Contact: Tingting Long, MD,Phd    +86 13549682646    longtingting@csu.edu.cn   
Sponsors and Collaborators
Xiangya Hospital of Central South University
Investigators
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Principal Investigator: Tingting Long, MD,Phd Department of PET Center,Xiangya Hospital, Central South University

Publications of Results:
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Responsible Party: Xiangya Hospital of Central South University
ClinicalTrials.gov Identifier: NCT03511768     History of Changes
Other Study ID Numbers: 201801001
First Posted: April 30, 2018    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiangya Hospital of Central South University:
18F-AlF-NOTA-octreotide
Additional relevant MeSH terms:
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Neuroendocrine Tumors
Neoplasms
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Octreotide
Gastrointestinal Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents