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

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

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs041190064
Enrollment
400
Registered
2019-09-02
Start date
2019-11-01
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain and spinal tumor

Interventions

the administration of high dose Indocyanin green

Sponsors

MUTO Jun
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Contacts

Public ContactJun MUTO

Fujita Health University Department of Neurosurgery

muto@fujita-hu.ac.jp+81-562-93-9253

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026