Thei intraoperative fluorecescene fluore by means of the indocyanine green and near infrated optical imaging

JRCT ID: jRCTs041190064

Registered date:02/09/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Brain and spinal tumor
• Date of first enrollment: 01/11/2019
• Target sample size: 310
• Study type: Interventional
• Intervention(s): the administration of high dose Indocyanin green

Outcome(s)

• Primary Outcome: The safety of intraoperative fluorescence imaging by ICG and the evaluation of the postoperative tumor volume enhanced by MRI taken within 72 hors after surgery

Secondary Outcome

The efficacy: disease free survival, overall survival, neurological findings (1month, 3months, 12 months after the surgery) In patients who were resected totally the enhanced lesion on MRI or CT scans

The safety; clinical and hematological side effects in 1 day, 1 week, 1 months after the surgery

Key inclusion & exclusion criteria

• Age minimum: >= 6age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

The following patients WILL BE included in the study
1.Those who are diagnosed to have brain or spinal tumor by CT scan or MRI
2. Those who do not possess any serious hematological and renal conditions, physical examination findings, and past medical history including familial history
3.Those who are be able to sign a written informed consent. However, if incapacitated, a legal surrogate may consent on his/her behalf
4. Those who are younger 18 years and older 75 years of age, regardless of gender; and
5. Those who will undergo surgical treatment.

Exclude criteria

The following patients WILL BE excluded FROM the study
1. Those who have an allergy for iodine
2. Those who have a creatine clearance of lower 30 mL .min (Cockroft-Gault)
3. Those who are taking biguanides for diabetes mellitus
4. Those who have dementia or any psychiatric disease
5. Those who have a concomitant hepatic dysfunction, Gamma GTP more than 100, proton-beam time less than 60%, bilirubin more than 51 micro mol. L
6. Those who are pregnant
7. Those who are receiving hemodialysis treatment
8.Those who do not consent, may remove this part since it was already mentioned in the inclusion
9. Those who will be undergoing further examinations, other than the present study, necessitating iodine contrast, to avoid potential toxicity
10. And those who are deemed not appropriate for the study as evaluated by the any of the investigators.

Related Information

• Primary Sponsor: MUTO Jun
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research,THE NITTO FOUNDATION