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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

Tracking Information
First Submitted Date  ICMJE April 17, 2018
First Posted Date  ICMJE April 30, 2018
Last Update Posted Date April 30, 2018
Actual Study Start Date  ICMJE January 2, 2018
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2018)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
Official Title  ICMJE A Study of 18F-AlF-NOTA-octreotide PET/CT for Imaging Neuroendocrine Neoplasms
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Neuroendocrine Neoplasm
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: 18F-AlF-NOTA-octreotide PET/CT
One injection of the radioligand 18F-AlF-NOTA-octreotide
Interventions:
  • Drug: 18F-AlF-NOTA-octreotide
  • Device: PET/CT
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 17, 2018)
65
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date December 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Tingting Long, MD,Phd +86 13549682646 longtingting@csu.edu.cn
Contact: Shuo Hu, professor +86 15874210819 hushuo_xy@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03511768
Other Study ID Numbers  ICMJE 201801001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Xiangya Hospital of Central South University
Study Sponsor  ICMJE Xiangya Hospital of Central South University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Tingting Long, MD,Phd Department of PET Center,Xiangya Hospital, Central South University
PRS Account Xiangya Hospital of Central South University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP