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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

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.

Condition or disease Intervention/treatment Phase
Pulmonary Sarcoidosis Drug: Methionine Drug: DOTANOC Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Study Start Date : May 2016
Estimated Primary Completion Date : May 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sarcoidosis

Arm Intervention/treatment
Experimental: C11-methionine
To compare FDG and C11-methionine in the detection of sarcoidotic lesions.
Drug: Methionine
Subject undergoes imaging studies with FDG and with methionine.
Other Name: PET tracers

Experimental: 68Ga-Dotanoc
To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.
Drug: DOTANOC
Subject undergoes imaging studies with FDG and with DOTANOC.
Other Name: PET tracers




Primary Outcome Measures :
  1. The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC. [ Time Frame: baseline ]
    Qualitative assessment of tracer uptake in sarcoidotic lesions.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with sarcoidosis

Exclusion Criteria:

  • any malignant disease
  • any significant other inflammatory or infectious disease affecting lungs
  • pregnancy

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): NCT02824419


Contacts
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Contact: Riikka Lautamaki, MD, PhD +3582 3130000 riikka.lautamaki@tyks.fi

Locations
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Finland
Turku University Hospital Recruiting
Turku, Varsinais-Suomi, Finland, 20520
Contact: Riikka Lautamaki, MD, PhD    +358 2 313 0000    riikka.lautamaki@tyks.fi   
Contact: Juhani Knuuti, MD, PhD    +358 2 313 0000      
Sponsors and Collaborators
Turku University Hospital
Investigators
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Principal Investigator: Juhani Knuuti, MD, PhD Turku PET Centre, Turku University Hospital, Turku, Finland
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Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT02824419    
Other Study ID Numbers: T16/2015
First Posted: July 6, 2016    Key Record Dates
Last Update Posted: July 6, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Granuloma
Lymphoproliferative Disorders
Lymphatic Diseases
Pathologic Processes
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases