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

Phase 2

• Conditions: Pulmonary Sarcoidosis
• Interventions: Drug: DOTANOC; Drug: Methionine

• Registration Number: NCT02824419
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-27
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-01
• Last Update Submitted: 2016-07-01
• Study First Posted: 2016-07-06
• Last Update Posted: 2016-07-06
• Primary Completion: 2017-05
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patient with sarcoidosis

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
68Ga-Dotanoc	DOTANOC	To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.
C11-methionine	Methionine	To compare FDG and C11-methionine in the detection of sarcoidotic lesions.

Primary Outcome Measures

Name	Time	Method
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.	baseline	Qualitative assessment of tracer uptake in sarcoidotic lesions.

Trial Locations

Locations (1)

Turku University Hospital; 🇫🇮 Turku, Varsinais-Suomi, Finland