Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
Healthy Volunteers
ID06330818

IMAGINE - Imaging in Moyamoya Disease to Compare MRI and PET/CT Techniques for Evaluating Brain Blood Flow and Disease Activity

Led by University Hospital Tuebingen · Updated on 2024-09-26

50

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

Sponsors

U

University Hospital Tuebingen

Lead Sponsor

U

University Hospital Freiburg

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to improve care for patients with Moyamoya Disease by advancing imaging techniques to better understand cerebral blood flow, disease activity, and progression. Moyamoya Disease is a rare condition characterized by narrowing or blockage of arteries in the brain, leading to risks of stroke. The study focuses on comparing CO2-triggered BOLD MRI with H2 15O PET/CT imaging, investigating vessel-wall changes, and correlating imaging findings with blood samples to uncover factors involved in disease progression. Participants will undergo special MRI scans including CO2-triggered BOLD MRI, vessel-wall imaging, and resting-state BOLD MRI to assess brain blood flow and disease activity. They will also have H2 15O PET/CT scans with an acetazolamide challenge for comparison. Blood samples will be collected to analyze circulating endothelial cells and viral markers. The study includes a two-year follow-up with standardized imaging, neuropsychological tests, and biosampling. Healthy volunteers and patients with intracerebral atherosclerotic disease will serve as comparison groups. Throughout the study, participants will have multiple imaging sessions and blood tests over up to 24 months. Researchers will measure how well CO2-triggered BOLD MRI matches PET/CT results, monitor vessel wall contrast changes, and track biological markers in blood. Neuropsychological assessments will evaluate brain function related to disease status. This study aims to develop imaging recommendations for pre- and postoperative evaluation of Moyamoya patients and provide insights into disease mechanisms and progression.

CONDITIONS

Brief Title

Imaging in Moyamoya Disease - Study to Investigate Different Imaging Technologies for a Better Understanding of Various Imaging Techniques to Evaluate Cerebral Hemodynamics, Disease-activity and Possibly the Etiology in Moyamoya Patients

Who Can Participate

Age: 18Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with suspicion of Moyamoya Disease
  • Patients able to understand the study and to give their informed consent
Not Eligible

You will not qualify if you...

  • Cerebral vascular disease caused by atherosclerosis
  • Vasculitis
  • Contraindications to MRI
  • Contraindications to PET/CT
  • Pregnancy
  • Inability to give informed consent
  • Renal insufficiency

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 24 months

Participants undergo specialized imaging tests including CO2-triggered BOLD MRI, vessel-wall imaging, resting state BOLD MRI, and H2 15O PET/CT with acetazolamide challenge, along with blood sampling to evaluate cerebral vasoreactivity and disease activity.

Multiple imaging and blood sampling visits over 24 months

Long-term Monitoring

Duration - Up to 24 months

Participants are monitored over time with repeated imaging and biosampling to observe disease progression and correlate findings with clinical outcomes.

Follow-up visits scheduled throughout the 24-month period

Trial Site Locations

Total: 1 location

1

University of Tuebingen, Neurosurgery

Tübingen, Baden-Wurttemberg, Germany, 72076

Actively Recruiting

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Research Team

C

Constantin Roder, Prof. Dr., MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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