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

Sponsor
Turku University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT02824419
Collaborator
(none)
10
Enrollment
1
Location
2
Arms
19
Duration (Months)
0.5
Patients Per Site Per Month

Study Details

Study Description

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
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.

Study Design

Study Type:
Interventional
Anticipated 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 1, 2016
Anticipated Primary Completion Date :
May 1, 2017
Anticipated Study Completion Date :
Dec 1, 2017

Arms and Interventions

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 Names:
  • 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 Names:
  • PET tracers

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC. [baseline]

      Qualitative assessment of tracer uptake in sarcoidotic lesions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient with sarcoidosis
    Exclusion Criteria:

    • any malignant disease

    • any significant other inflammatory or infectious disease affecting lungs

    • pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Turku University Hospital Turku Varsinais-Suomi Finland 20520

    Sponsors and Collaborators

    • Turku University Hospital

    Investigators

    • Principal Investigator: Juhani Knuuti, MD, PhD, Turku PET Centre, Turku University Hospital, Turku, Finland

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Turku University Hospital
    ClinicalTrials.gov Identifier:
    NCT02824419
    Other Study ID Numbers:
    • T16/2015
    First Posted:
    Jul 6, 2016
    Last Update Posted:
    Jul 6, 2016
    Last Verified:
    Jul 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Sarcoidosis, Pulmonary
    Sarcoidosis
    Granuloma

    Study Results

    No Results Posted as of Jul 6, 2016