Image quality evaluation of cerebral angiography with diluted contrast media

JRCT ID: jRCTs031230448

Registered date:16/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients undergoing diagnosis of unruptured aneurysms
• Date of first enrollment: 12/12/2023
• Target sample size: 22
• Study type: Interventional
• Intervention(s): Diagnosis of unruptured aneurysms using angiography equipment; DSA (F/L) and 3DRA using undiluted contrast medium followed by additional identical imaging using diluted contrast medium, respectively.

Outcome(s)

• Primary Outcome: Verification of non-inferiority of 50% diluted contrast agent image quality over undiluted contrast agent image quality in cerebral angiography (DSA and 3DRA)

Secondary Outcome

Non-inferiority verification of the ability to visualize cerebral microvessels (target vessels for each imaging)
DSA: ICA, MCA, perforator, specific veins
3DRA: Extraction of perforator, Acom, Pcom, Ant. choroidal arterynoids

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1) Patients consenting to treatment/diagnosis of unruptured aneurysm, DSA (F/L) imaging with conventional contrast and 3DRA imaging with additional diluted contrast.
2) Patients who have been informed of the study and who have given written consent of their own free will after full understanding of the study.
3) Male and female patients aged 18 years or older at the time of consent.

Exclude criteria

1) Patients with giant aneurysms (>25 mm diameter)
2) Patients with renal dysfunction or suspected renal dysfunction (eGFR <60)
3) Pregnant women or women of childbearing potential
4) Other patients deemed inappropriate by the principal investigator/associate investigator

Related Information

• Primary Sponsor: Matsumaru Yuji
• Secondary Sponsor: Philips Medical Systems Netherlands B.V.