PET-imaging of Unruptured Intracranial Aneurysm Inflammation (PET-IA)

January 14, 2021 updated by: Jaakko Rinne, Turku University Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Finland
      • Turku, Finland, 20521
        • Recruiting
        • Turku University Hospital
        • Contact:
        • Principal Investigator:
          • Jaakko Rinne, MD, Prof.
        • Sub-Investigator:
          • Dan Laukka, MD
        • Sub-Investigator:
          • Antti Saraste, MD, Prof.
        • Sub-Investigator:
          • Melissa Rahi, MD, PhD
        • Sub-Investigator:
          • Juri Kivelev, MD, PhD
        • Sub-Investigator:
          • Johanna Kuhmonen, MD, PhD
        • Sub-Investigator:
          • Riitta Parkkola, MD, Prof
        • Sub-Investigator:
          • Maria Gardberg, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: PET-IA
68Ga-DOTANOC 18F-FDG
Radiation: PET imaging, 18F-FDG
PET-MRI with 18F-FDG
Radiation: PET imaging, 68Ga-DOTANOC
PET-CT with 68Ga-DOTANOC

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Risk factors for intracranial aneurysm inflammation
Time Frame: 1 month
Uptake of 18F-FDG or 68Ga-DOTANOC and histological findings correlation to aneurysm size and shape, smoking, hypertension, location of aneurysm.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Turku University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Turku

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jaakko Rinne, MD, Prof., Turku University Hospital, Neurocenter, Department of Neurosurgery, Division of Clinical Neurosciences, University Of Turku
  • Study Director: Antti Saraste, MD, Prof., Turku University Hospital, Heart Centre, University of Turku

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 20, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • T225/2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Inflammation

Clinical Trials on PET imaging, 18F-FDG

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings