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Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis

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ClinicalTrials.gov Identifier: NCT02824419
Recruitment Status : Unknown
Verified July 2016 by Turku University Hospital.
Recruitment status was:  Recruiting
First Posted : July 6, 2016
Last Update Posted : July 6, 2016
Sponsor:
Information provided by (Responsible Party):
Turku University Hospital

Tracking Information
First Submitted Date  ICMJE May 27, 2016
First Posted Date  ICMJE July 6, 2016
Last Update Posted Date July 6, 2016
Study Start Date  ICMJE May 2016
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 1, 2016)
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC. [ Time Frame: baseline ]
Qualitative assessment of tracer uptake in sarcoidotic lesions.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Official Title  ICMJE Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Brief Summary The goal of the current study is to evaluate the potential of the selected PET tracers to detect sarcoidotic lesions in lungs. The tracers are already in clinical use for the detection of certain inflammatory processes or malignant tumors, and their targets present similarities with molecular mechanisms of sarcoidosis.
Detailed Description

The diagnosis of sarcoidosis is difficult since there is no specific noninvasive method available to diagnose sarcoidosis. FDG-PET imaging is in use, however, FDG is not a specific tracer for sarcoidosis and other inflammatory diseases may interfere with the imaging findings. The aim of the current protocol is to evaluate the potential of other inflammatory PET-tracers in the detection of sarcoidotic lesions.

The patients with active sarcoidotic lesions in lungs will be recruited. First, the patient undergoes PET-FDG scan and then the patient undergoes the PET scan either with C11-methionine or 68Ga-DOTANOC. The results with the latter tracers will be compared to the imaging results with FDG.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Pulmonary Sarcoidosis
Intervention  ICMJE
  • Drug: Methionine
    Subject undergoes imaging studies with FDG and with methionine.
    Other Name: PET tracers
  • Drug: DOTANOC
    Subject undergoes imaging studies with FDG and with DOTANOC.
    Other Name: PET tracers
Study Arms  ICMJE
  • Experimental: C11-methionine
    To compare FDG and C11-methionine in the detection of sarcoidotic lesions.
    Intervention: Drug: Methionine
  • Experimental: 68Ga-Dotanoc
    To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.
    Intervention: Drug: DOTANOC
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 1, 2016)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date May 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient with sarcoidosis

Exclusion Criteria:

  • any malignant disease
  • any significant other inflammatory or infectious disease affecting lungs
  • pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02824419
Other Study ID Numbers  ICMJE T16/2015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Turku University Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Turku University Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Juhani Knuuti, MD, PhD Turku PET Centre, Turku University Hospital, Turku, Finland
PRS Account Turku University Hospital
Verification Date July 2016

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