Back to resultsImaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Primary Purpose
Pulmonary Sarcoidosis
Status
Unknown status
Phase
Phase 2
Locations
Finland
Study Type
Interventional
Intervention
Methionine
DOTANOC
Sponsored by
About this trial
This is an interventional diagnostic trial for Pulmonary Sarcoidosis
Eligibility Criteria
Inclusion Criteria:
- Patient with sarcoidosis
Exclusion Criteria:
- any malignant disease
- any significant other inflammatory or infectious disease affecting lungs
- pregnancy
Sites / Locations
- Turku University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
C11-methionine
68Ga-Dotanoc
Arm Description
To compare FDG and C11-methionine in the detection of sarcoidotic lesions.
To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.
Outcomes
Primary Outcome Measures
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.
Qualitative assessment of tracer uptake in sarcoidotic lesions.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02824419
Brief Title
Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Official Title
Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Turku University Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Sarcoidosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
C11-methionine
Arm Type
Experimental
Arm Description
To compare FDG and C11-methionine in the detection of sarcoidotic lesions.
Arm Title
68Ga-Dotanoc
Arm Type
Experimental
Arm Description
To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.
Intervention Type
Drug
Intervention Name(s)
Methionine
Other Intervention Name(s)
PET tracers
Intervention Description
Subject undergoes imaging studies with FDG and with methionine.
Intervention Type
Drug
Intervention Name(s)
DOTANOC
Other Intervention Name(s)
PET tracers
Intervention Description
Subject undergoes imaging studies with FDG and with DOTANOC.
Primary Outcome Measure Information:
Title
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.
Description
Qualitative assessment of tracer uptake in sarcoidotic lesions.
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient with sarcoidosis
Exclusion Criteria:
any malignant disease
any significant other inflammatory or infectious disease affecting lungs
pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riikka Lautamaki, MD, PhD
Phone
+3582 3130000
Email
riikka.lautamaki@tyks.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juhani Knuuti, MD, PhD
Organizational Affiliation
Turku PET Centre, Turku University Hospital, Turku, Finland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Turku University Hospital
City
Turku
State/Province
Varsinais-Suomi
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riikka Lautamaki, MD, PhD
Phone
+358 2 313 0000
Email
riikka.lautamaki@tyks.fi
First Name & Middle Initial & Last Name & Degree
Juhani Knuuti, MD, PhD
Phone
+358 2 313 0000
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
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