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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 2 May 2016
Main ID:  EUCTR2015-001815-11-FI
Date of registration: 29/12/2015
Prospective Registration: Yes
Primary sponsor: Turku PET Centre
Public title: PET imaging of pulmonary sarcoidosis
Scientific title: Imaging of active granulomas with [18F]FDG and selected inflammatory PET tracers in pulmonary sarcoidosis
Date of first enrolment: 19/04/2016
Target sample size:
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001815-11
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Finland
Contacts
Name: Turku PET Centre   
Address:  TYKS Valtakunnallinen PET-keskus 20520 Turku Finland
Telephone:
Email:
Affiliation:  Turku PET Centre
Name: Turku PET Centre   
Address:  TYKS Valtakunnallinen PET-keskus 20520 Turku Finland
Telephone:
Email:
Affiliation:  Turku PET Centre
Key inclusion & exclusion 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:
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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
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
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Intervention(s)

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)
Concentration type: range
Concentration number: 170-185

Product Name: C11-methionine
Pharmaceutical Form: Infusion
INN or Proposed INN: L-methionine
Other descriptive name: L-METHIONINE ([11C]METHYL)
Concentration unit: MBq megabecquerel(s)
Concentration type: range
Concentration number: 400-440

Product Name: 68Ga-DOTANOC
Pharmaceutical Form: Infusion
INN or Proposed INN: DOTANOC
Other descriptive name: DOTANOC
Concentration unit: MBq megabecquerel(s)
Concentration type: range
Concentration number: 170-185

Primary Outcome(s)
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.
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.
Secondary Objective: Not applicaple
Timepoint(s) of evaluation of this end point: After the first imaging scan with FDG.
Secondary Outcome(s)
Secondary end point(s): Not applicaple
Timepoint(s) of evaluation of this end point: Not applicaple
Secondary ID(s)
sarcoid1
Source(s) of Monetary Support
Turku PET Centre
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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