Intracranial AneurysmPET-IANCT04715503
PET-imaging of Unruptured Intracranial Aneurysm Inflammation
A study testing PET imaging, 18F-FDG and PET imaging, 68Ga-DOTANOC in people with Intracranial Aneurysm and Cerebral Aneurysm, run by Turku University Hospital at 1 site in Finland.
Trial summary
The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Aneurysm, Cerebral Aneurysm, Inflammation
- What is being tested?
- PET imaging, 18F-FDG and PET imaging, 68Ga-DOTANOC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteFinland
- Study dates
- 14 Jan 2021to Oct 2022
- Phase
- Interventional
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Fusiform intracranial aneurysms
- Following medications: Asetylsalisylic acid or non-steroidal anti-inflammatory drugs.
- Patients who have contraindication for magnetic resonance imaging (Pace Makers, foreign ferromagnetic bodies or implants)
- Patients who are allergic to contrast agents.
- Pregnancy
- Underage persons
- Patients on somatostatin analogue medication or with known neuroendocrine tumor
Who cannot join
- Patients who are diagnosed with unruptured intracranial aneurysm with MRI/MRA or DSA
- Patients who are planned to undergo surgical treatment (ligation) of the intracranial aneurysm
- Age ≥18 and <75 years.
- Saccular intracranial aneurysm with maximum diameter ≥ 3 mm.
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Turku University Hospital
Turku, 20521
Dan Laukka, MD, +358 2 313 2799, dan.laukka@tyks.fi
Jaakko Rinne, MD, Prof.
About this study
The main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.
Read the detailed description
Study subjects are patients who are diagnosed with an unruptured saccular intracranial aneurysm and planned for elective surgical treatment of intracranial aneurysms. Prior the planned surgery, all study subjects will undergo PET-imaging of the brain with 18F-FDG- and 68Ga-DOTANOC-tracers targeting glucose metabolism and somatostatin receptors in inflammatory cells. After PET-imaging, samples for histopathological examination from the intracranial aneurysm sac will be collected during the surgery from every study subject. Blood samples are collected prior to aneurysm operation from the routine pre-operative laboratory tests. Cerebrospinal fluid samples are collected during the surgical procedure from the surgical site. From blood samples we will evaluate expression of 20 different circulating microRNAs (miRNA) and the level of tumor necrosis factor-1, interleukin 1 beta, vascular endothelial growth factor, and evaluate correlations between miRNA expression and SUVmax in PET-imaging and miRNA and aneurysm histological findings.
Correlation between inflammatory findings in histological studies and PET-imaging will be evaluated (correlation of SUVmax to aneurysm histological findings).
- Conditions
- Intracranial Aneurysm, Cerebral Aneurysm, Inflammation
- Being tested
- PET imaging, 18F-FDG, PET imaging, 68Ga-DOTANOC
- Keywords
- intracranial aneurysm, PET, inflammation, positron emission tomography, rupture risk
- Medical subject headings
- Intracranial Aneurysm, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imaging, 18F-FDGRadiation
PET-MRI with 18F-FDG
PET imaging, 68Ga-DOTANOCRadiation
PET-CT with 68Ga-DOTANOC
| Study group | Role | What they receive |
|---|---|---|
| PET-IA | Experimental | 68Ga-DOTANOC 18F-FDG Receives: Radiation: PET imaging, 18F-FDG; Radiation: PET imaging, 68Ga-DOTANOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET-imaging of unruptured intracranial aneurysms
Uptake of 18F-FDG or 68Ga-DOTANOC in intracranial arterial aneurysms as compared to contra-lateral normal vessel as SUVmax or TBR.
Correlation of uptake of 18F-FDG or 68Ga-DOTANOC (SUVmax or TBR) to aneurysm histological findings (CD45, CD3, CD5, CD20, CD138 and CD68, SSTR2, SSTR3 and SSTR5)
Measured: 1 month
Secondary outcomes (1)
Risk factors for intracranial aneurysm inflammation
Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2021
- Study start14 Jan 2021
- Primary completionJan 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intracranial AneurysmStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Turku University Hospital
- Sponsor type
- Other government
- Collaborators
- University of Turku
- Responsible party
- Principal investigator, Jaakko Rinne, Turku University Hospital
- Investigators
- Jaakko Rinne, MD, Prof., Principal investigator, Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of TurkuAntti Saraste, MD, Prof., Study director, Turku University Hospital, Heart Centre, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04715503
- Sponsor's protocol ID
- T225/2020
- Acronym
- PET-IA
- Status last verified
- Jan 2021
- First submitted
- 14 Jan 2021
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Laukka D, Paturi J, Rahi M, Saraste A, Parkkola R, Kivelev J, Gardberg M, Kuhmonen J, Rinne J. PET imaging of unruptured intracranial aneurysm inflammation (PET-IA) study: a feasibility study protocol. BMJ Open. 2024 Feb 20;14(2):e076764. doi: 10.1136/bmjopen-2023-076764.
PubMed 38382960
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PET-imaging of Unruptured Intracranial Aneurysm Inflammation
- ClinicalTrials.gov ID
- NCT04715503
- Acronym / sponsor ID
- PET-IA / T225/2020
- Conditions
- Intracranial Aneurysm, Cerebral Aneurysm, Inflammation
- Keywords
- intracranial aneurysm, PET, inflammation, positron emission tomography, rupture risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Turku University HospitalOther government
- Collaborators
- University of Turku
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 20 Jan 2021 (actual)
- 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 main purpose of this study is to determine if PET-imaging can be used to evaluate inflammation level of intracranial aneurysms, thus helping to evaluate the rupture risk of intracranial aneurysm.
Detailed description
Study subjects are patients who are diagnosed with an unruptured saccular intracranial aneurysm and planned for elective surgical treatment of intracranial aneurysms. Prior the planned surgery, all study subjects will undergo PET-imaging of the brain with 18F-FDG- and 68Ga-DOTANOC-tracers targeting glucose metabolism and somatostatin receptors in inflammatory cells. After PET-imaging, samples for histopathological examination from the intracranial aneurysm sac will be collected during the surgery from every study subject. Blood samples are collected prior to aneurysm operation from the routine pre-operative laboratory tests. Cerebrospinal fluid samples are collected during the surgical procedure from the surgical site. From blood samples we will evaluate expression of 20 different circulating microRNAs (miRNA) and the level of tumor necrosis factor-1, interleukin 1 beta, vascular endothelial growth factor, and evaluate correlations between miRNA expression and SUVmax in PET-imaging and miRNA and aneurysm histological findings.
Correlation between inflammatory findings in histological studies and PET-imaging will be evaluated (correlation of SUVmax to aneurysm histological findings).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET-IA | Experimental | Radiation: PET imaging, 18F-FDG, Radiation: PET imaging, 68Ga-DOTANOC68Ga-DOTANOC 18F-FDG |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Fusiform intracranial aneurysms
- Following medications: Asetylsalisylic acid or non-steroidal anti-inflammatory drugs.
- Patients who have contraindication for magnetic resonance imaging (Pace Makers, foreign ferromagnetic bodies or implants)
- Patients who are allergic to contrast agents.
- Pregnancy
Key exclusion criteria (4 listed)
- Patients who are diagnosed with unruptured intracranial aneurysm with MRI/MRA or DSA
- Patients who are planned to undergo surgical treatment (ligation) of the intracranial aneurysm
- Age ≥18 and <75 years.
- Saccular intracranial aneurysm with maximum diameter ≥ 3 mm.
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 |
|---|---|---|
| PET imaging, 18F-FDGPET-MRI with 18F-FDG | Radiation | PET-IA |
| PET imaging, 68Ga-DOTANOCPET-CT with 68Ga-DOTANOC | Radiation | PET-IA |
Primary outcome
PET-imaging of unruptured intracranial aneurysms
Time frame: 1 month
Uptake of 18F-FDG or 68Ga-DOTANOC in intracranial arterial aneurysms as compared to contra-lateral normal vessel as SUVmax or TBR. Correlation of uptake of 18F-FDG or 68Ga-DOTANOC (SUVmax or TBR) to aneurysm histological findings (CD45, CD3, CD5, CD20, CD138 and CD68, SSTR2, SSTR3 and SSTR5)
1 secondary outcome
Risk factors for intracranial aneurysm inflammation
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Derived from this study: PubMed 38382960Laukka D, Paturi J, Rahi M, Saraste A, Parkkola R, Kivelev J, Gardberg M, Kuhmonen J, Rinne J. PET imaging of unruptured intracranial aneurysm inflammation (PET-IA) study: a feasibility study protocol. BMJ Open. 2024 Feb 20;14(2):e076764. doi: 10.1136/bmjopen-2023-076764.
- Individual participant dataSharing planned: Undecided
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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.
Jaakko Rinne, MD, Prof. principal investigator
Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku
Antti Saraste, MD, Prof. study director
Turku University Hospital, Heart Centre, University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET imaging, 18F-FDG and PET imaging, 68Ga-DOTANOC in people with Intracranial Aneurysm and Cerebral Aneurysm, 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 7 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 Jan 2021. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dan Laukka, MD (+358 2 313 2799, dan.laukka@tyks.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET-imaging of unruptured intracranial aneurysms (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04715503, which also lists 1 linked publication.
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 20 Jan 2021.