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

• ClinicalTrials.gov Identifier: NCT02824419
• Recruitment Status: Unknown
• First Posted: July 6, 2016
• Last Update Posted: July 6, 2016
• Sponsor: Turku University Hospital
• Information provided by (Responsible Party): Turku University Hospital

Tracking Information

• First Submitted Date: May 27, 2016
• First Posted Date: July 6, 2016
• Last Update Posted Date: July 6, 2016
• Study Start Date: May 2016
• Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 1, 2016)

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

Qualitative assessment of tracer uptake in sarcoidotic lesions.

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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 Type: Interventional
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Pulmonary Sarcoidosis

Intervention

• Drug: Methionine
  Subject undergoes imaging studies with FDG and with methionine.
  Other Name: PET tracers
• Drug: DOTANOC
  Subject undergoes imaging studies with FDG and with DOTANOC.
  Other Name: PET tracers

Study Arms

• Experimental: C11-methionine
  To compare FDG and C11-methionine in the detection of sarcoidotic lesions.
  Intervention: Drug: Methionine
• Experimental: 68Ga-Dotanoc
  To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.
  Intervention: Drug: DOTANOC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 1, 2016): 10
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2017
• Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patient with sarcoidosis

Exclusion Criteria:

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Finland

Administrative Information

• NCT Number: NCT02824419
• Other Study ID Numbers: T16/2015
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Turku University Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Turku University Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Turku University Hospital
• Verification Date: July 2016