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

July 1, 2016 updated by: Turku University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

10

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Contact:
          • Juhani Knuuti, MD, PhD
          • Phone Number: +358 2 313 0000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with sarcoidosis

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.
Time Frame: baseline
Qualitative assessment of tracer uptake in sarcoidotic lesions.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Turku University Hospital

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (ANTICIPATED)

May 1, 2017

Study Completion (ANTICIPATED)

December 1, 2017

Study Registration Dates

First Submitted

May 27, 2016

First Submitted That Met QC Criteria

July 1, 2016

First Posted (ESTIMATE)

July 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

July 6, 2016

Last Update Submitted That Met QC Criteria

July 1, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • T16/2015

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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