PET imaging of pulmonary sarcoidosis

• Register: EUCTR
• Last refreshed on: 14 October 2024
• 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: 10
• Recruitment status: Not Recruiting
• 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: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Finland

Contacts

• Name: Turku PET Centre
• Affiliation: Turku PET Centre

• Name: Turku PET Centre
• 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

Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

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

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)

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.

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

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: Not applicaple

Secondary end point(s): Not applicaple

Secondary ID(s)

sarcoid1

Source(s) of Monetary Support

Turku PET Centre

Ethics review

Status: Approved
Approval date: 19/04/2016
Contact: