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

Pulmonary Sarcoidosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02824419
• Other study ID #: T16/2015
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: May 27, 2016
• Last updated: July 1, 2016
• Start date: May 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2016
• Source: Turku University Hospital
• Contact: Riikka Lautamaki, MD, PhD
• Phone: +3582 3130000
• Email: riikka.lautamaki[@]tyks.fi
• Is FDA regulated: No
• Health authority: Finland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: December 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient with sarcoidosis

Exclusion Criteria:

• any malignant disease

• any significant other inflammatory or infectious disease affecting lungs

• pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Pulmonary Sarcoidosis
• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Drug:
• Methionine
Subject undergoes imaging studies with FDG and with methionine.
• DOTANOC
Subject undergoes imaging studies with FDG and with DOTANOC.

Locations

Country	Name	City	State
Finland	Turku University Hospital	Turku	Varsinais-Suomi

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.	Qualitative assessment of tracer uptake in sarcoidotic lesions.	baseline	No