Exploratory Study on the Efficacy of "Boosted CT Myelography"

JRCT ID: jRCTs061230076

Registered date:13/11/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: cerebrospinal fluid hypovolemia
• Date of first enrollment: 13/11/2023
• Target sample size: 6
• Study type: Interventional
• Intervention(s): Perform lumbar puncture using the same technique as CT myelography, and inject 10 mL of Isovist 240 intrathecally. After intrathecal administration of Isovist 240, the patient should remain in bed rest for 30 minutes. Subsequently, the patient should be encouraged to move lightly to prevent the contrast agent from settling. After one hour, perform lumbar puncture again using the same technique, and inject 10 mL of ARTCEREB intrathecally. Immediately after intrathecal administration of ARTCEREB, obtain a CT scan as quickly as possible. If no adverse events are observed one hour after intrathecal administration of ARTCEREB, the patient may be allowed to go home. One week after intrathecal administration of ARTCEREB, conduct a follow-up examination or confirm adverse events over the phone to conclude the study.

Outcome(s)

• Primary Outcome: The percentage of identified leakage sites of cerebrospinal fluid using boosted CT Myelography.

Secondary Outcome

(1) Complications such as bleeding and neurological disorders associated with the implementation of boosted CT myelography.
(2) Side effects such as headache, dizziness, nausea, and fever associated with intrathecal injection of ARTCEREB.
(3) Overall mortality.
(4) Other adverse events.

Key inclusion & exclusion criteria

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

Include criteria

(1) Patients whose cerebrospinal fluid pressure has been confirmed to be less than 10 cmH2O at least once in the past and who are strongly suspected of having cerebrospinal fluid depletion.
(2) Patients in whom leakage sites cannot be identified by CT myelography
(3) Age 18 and above at the time of consent acquisition (gender unspecified)

Exclude criteria

(1) Patients with suspected symptoms of contrast agent allergy in the past
(2) Patients with other acute illnesses
(3) Pregnant women

Related Information

• Primary Sponsor: Eiichi Nakai