PET imaging of pulmonary sarcoidosis

Imaging of active granulomas with [18F]FDG and selected inflammatory PET tracers in pulmonary sarcoidosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001815-11-FI

Enrollment

Registered

2015-12-29

Start date

2016-04-19

Completion date

Unknown

Last updated

2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary sarcoidosis with active garnulomas in the lungs. The diagnosis is based on the clinical evidence or biopsy. MedDRA version: 18.1 Level: PT Classification code 10037430 Term: Pulmonary sarcoidosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

Interventions

Product Name: 18F-fluorodeoxyglucose Product Code: FDG Pharmaceutical Form: Infusion INN or Proposed INN: FLUORINE (18F) FLUDEOXYGLUCOSE CAS Number: 105851-17-0 Concentration unit: MBq megabecquerel(s

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Male or female patients with sarcoidosis . Diagnosis is primarily based on the clinical evidence and if atypical it is confirmed by biopsy. 2) Age > 18 years Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1) Any malignant disease 2) Any significant other inflammatory or infectious disease affecting lungs 3) Pregnancy or lactation 4) Physical, psychological, or logistic problems to participate in all protocol-defined procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: Not applicaple;Primary end point(s): The study consists of two separate imaging sessions. In the first part of the study, the subjects will undergo a PET imaging session of thoracic region with FDG for pulmonary lesions. If there is focal FDG uptake typical for sarcoidotic lesions detected in the lungs, the study subjects will enter the second phase of the study. In the second phase of the study, the study subjects will undergo another imaging study with an inflammation tracer of choice. For each tracer, five subjects will be studied. ;Timepoint(s) of evaluation of this end point: After the first imaging scan with FDG.	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: Not applicaple;Primary end point(s): The study consists of two separate imaging sessions. In the first part of the study, the subjects will undergo a PET imaging session of thoracic region with FDG for pulmonary lesions. If there is focal FDG uptake typical for sarcoidotic lesions detected in the lungs, the study subjects will enter the second phase of the study. In the second phase of the study, the study subjects will undergo another imaging study with an inflammation tracer of choice. For each tracer, five subjects will be studied. ;Timepoint(s) of evaluation of this end point: After the first imaging scan with FDG.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicaple;Timepoint(s) of evaluation of this end point: Not applicaple	—

Countries

Finland

Contacts

Public ContactTurku PET Centre

Turku PET Centre

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026