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

NCT ID: NCT02824419

Last Updated: 2016-07-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Pulmonary Sarcoidosis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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C11-methionine

To compare FDG and C11-methionine in the detection of sarcoidotic lesions.

Group Type EXPERIMENTAL

Methionine

Intervention Type DRUG

Subject undergoes imaging studies with FDG and with methionine.

68Ga-Dotanoc

To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions.

Group Type EXPERIMENTAL

DOTANOC

Intervention Type DRUG

Subject undergoes imaging studies with FDG and with DOTANOC.

Interventions

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Methionine

Subject undergoes imaging studies with FDG and with methionine.

Intervention Type DRUG

DOTANOC

Subject undergoes imaging studies with FDG and with DOTANOC.

Intervention Type DRUG

Other Intervention Names

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PET tracers PET tracers

Eligibility Criteria

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Inclusion Criteria

* Patient with sarcoidosis

Exclusion Criteria

* any malignant disease
* any significant other inflammatory or infectious disease affecting lungs
* pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turku University Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Juhani Knuuti, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Turku PET Centre, Turku University Hospital, Turku, Finland

Locations

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Turku University Hospital

Turku, Southwest Finland, Finland

Site Status RECRUITING

Countries

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Finland

Central Contacts

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Riikka Lautamaki, MD, PhD

Role: CONTACT

+3582 3130000

Facility Contacts

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Riikka Lautamaki, MD, PhD

Role: primary

+358 2 313 0000

Juhani Knuuti, MD, PhD

Role: backup

+358 2 313 0000

Other Identifiers

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T16/2015

Identifier Type: -

Identifier Source: org_study_id

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