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

NCT06330818 | Recruiting DMC

• 2 other identifiers: IMAGINE Moyamoya528291394
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of this study is to improve patient care in Moyamoya Patients by improving Imaging technologies and aiming to identify factors involved in disease progression. Main tasks are:

• Analysis of CO2-triggered BOLD fMRI for analysis of cerebral hemodynamics in comparison to H2 15O PET/CT
• Analysis of longitudinal changes of contrast enhancement in vessel-wall imaging and correlation of disease activity with biosampling
• Definition of a standardized recommendation for pre- and postoperative imaging of Moyamoya patients

Conditions

Moyamoya Disease; Moyamoya

Keywords

Stroke; Moyamoya; EC-IC Bypass

Outcome Measures

Primary Outcomes (1)

• Value of CO2-triggered BOLD MRI compared to PET/CT

  Analysis of comparability of fMRI-based vasoreactivity and PET/CT based vasoreserve (Signal change in percent)

  From enrollment until maximum of 24 months

Secondary Outcomes (3)

• Vessel-Wall contrast enhancement

  From enrollment until maximum of 24 months

• Circulating endothelial cells

  From enrollment to a maximum of 24 months

• PCR-based virus sampling

  From enrollment until maximum 24 months

Study Arms (2)

Moyamoya patients

EXPERIMENTAL

Newly diagnosed Moyamoya patients who will follow a standardized imaging and biosampling protocol. Possible surgical or conservative treatment will not be influenced by this study.

Diagnostic Test: MRI; Diagnostic Test: H2 15O PET/CT; Other: Biosampling

Control group

NO INTERVENTION

Healthy patients and patients with intracerebral atherosclerotic disease are used as comparators for the results of biosampling.

Interventions

MRI DIAGNOSTIC_TEST

Patients will get special MRI sequences (CO2-triggered BOLD MRI, Vessel-wall imaging, resting state BOLD MRI) to identify cerebral vasoreactivity and disease activity.

Moyamoya patients

H2 15O PET/CT DIAGNOSTIC_TEST

Patients will get H2 15O PET/CT with acetazolamide challenge to define the cerebral vasoreserve for comparison with fMRI Images

Moyamoya patients

Biosampling OTHER

Patients do get a venous puncture for blood analysis on circulating endothelial cells and virus PCR analysis

Moyamoya patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with suspicion of Moyamoya Disease
• Patients able to understand the study and to give their informed consent

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Tuebingen: lead
• University Hospital Freiburg: collaborator

Study Sites (1)

University of Tuebingen, Neurosurgery

Tübingen, Baden-Wurttemberg, 72076, Germany

RECRUITING

MeSH Terms

Conditions

Moyamoya Disease; Stroke

Condition Hierarchy (Ancestors)

Carotid Artery Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Constantin Roder, Prof. Dr., MD

CONTACT

0049-7071290; constantin.roder@med.uni-tuebingen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 26, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): July 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

DE (1)