Pulmonary SarcoidosisPhase 2/3NCT02824419
Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
A Phase 2/3 study testing Methionine and DOTANOC in people with Pulmonary Sarcoidosis, run by Turku University Hospital at 1 site in Finland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Sarcoidosis
- What is being tested?
- Methionine and DOTANOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFinland
- Study dates
- May 2016to Dec 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient with sarcoidosis
Who cannot join
- any malignant disease
- any significant other inflammatory or infectious disease affecting lungs
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Pulmonary Sarcoidosis
- Being tested
- Methionine, DOTANOC
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethionineDrug
Also called PET tracers
Subject undergoes imaging studies with FDG and with methionine.
DOTANOCDrug
Also called PET tracers
Subject undergoes imaging studies with FDG and with DOTANOC.
| Study group | Role | What they receive |
|---|---|---|
| C11-methionine | Experimental | To compare FDG and C11-methionine in the detection of sarcoidotic lesions. Receives: Drug: Methionine |
| 68Ga-Dotanoc | Experimental | To compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions. Receives: Drug: DOTANOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.
Qualitative assessment of tracer uptake in sarcoidotic lesions.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study startMay 2016
- Primary completionFeb 2017
- Study completionDec 2017
Why it stopped: No significant uptake of studied traces were found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary SarcoidosisStudies of the same condition, open and under way.
- More trials run by Turku University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Juhani Knuuti, MD, PhD, Principal investigator, Turku PET Centre, Turku University Hospital, Turku, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02824419
- Sponsor's protocol ID
- T16/2015
- Status last verified
- Jun 2026
- First submitted
- 27 May 2016
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Imaging of Active Granulomas With [18F]FDG and Selected Inflammatory PET Tracers in Pulmonary Sarcoidosis
- ClinicalTrials.gov ID
- NCT02824419
- Acronym / sponsor ID
- T16/2015
- Conditions
- Pulmonary Sarcoidosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No significant uptake of studied traces were found.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Turku University HospitalOther government
- Study start
- May 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C11-methionine | Experimental | Drug: MethionineTo compare FDG and C11-methionine in the detection of sarcoidotic lesions. |
| 68Ga-Dotanoc | Experimental | Drug: DOTANOCTo compare FDG and 68Ga-DOTANOC in the detection of sarcoidotic lesions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient with sarcoidosis
Key exclusion criteria (3 listed)
- any malignant disease
- any significant other inflammatory or infectious disease affecting lungs
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethionineAlso: PET tracersSubject undergoes imaging studies with FDG and with methionine. | Drug | C11-methionine |
| DOTANOCAlso: PET tracersSubject undergoes imaging studies with FDG and with DOTANOC. | Drug | 68Ga-Dotanoc |
Primary outcome
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC.
Time frame: baseline
Qualitative assessment of tracer uptake in sarcoidotic lesions.
Results and safety
The study was stopped early (reason given: No significant uptake of studied traces were found.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Sarcoidosis
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Not yet recruitingPhase 2
An Efficacy Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extrapulmonary Manifestations
Pulmonary Sarcoidosis
Not yet recruitingPhase 2
LAM-001 for the Treatment of Sarcoidosis Associated Pulmonary Hypertension (SAPH)
Sarcoidosis Associated Pulmonary Hypertension
Not yet recruitingPhase 2/3
Evaluation of the Efficacy and Safety of Compound Betamethasone in Pulmonary Sarcoidosis
Sarcoidosis, Pulmonary
Not yet recruitingPhase 2
A Clinical Trial of Tulisokibart (MK-7240) in Participants With Pulmonary Sarcoidosis (MK-7240-016)
Pulmonary Sarcoidosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhani Knuuti, MD, PhD principal investigator
Turku PET Centre, Turku University Hospital, Turku, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Methionine and DOTANOC in people with Pulmonary Sarcoidosis, run by Turku University Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: No significant uptake of studied traces were found.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection of sarcoidotic lesion with C11-methionine or 68Ga-DOTANOC. (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2026.