Status:
COMPLETED
Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
Lead Sponsor:
Nobelpharma
Conditions:
Malignant Glioma
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a s...
Eligibility Criteria
Inclusion
- Aged between 18 and 70 years.
- Radiological suspicion of newly- or recurrent malignant glioma (WHO grades III/IV).
- Indication for surgical tumor resection.
- Karnofsky Performance Score of 60 or higher.
- Provides signed informed consent prior to any study procedures.
- Comply with visit schedule and other rules for patients in study protocol.
Exclusion
- Porphyria, hypersensitivity to porphyrins.
- Renal insufficiency: Creatinine 2.0 mg/dL or higher
- Hepatic insufficiency: ALT 100 IU/L or higher, AST 100 IU/L or higher, γ-GTP 100 IU/L or higher or total bilirubin 3 mg/dL or higher
- Chemotherapy or other treatment for other malignant tumors
- Females who are pregnant or potentially childbearing or are breastfeeding
- Participation in other clinical trial in the previous 1 month
- Ineligible patient based on the judgement of the investigator.
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01167322
Start Date
August 1 2010
End Date
December 1 2011
Last Update
April 27 2012
Active Locations (3)
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1
International Medical Center, Saitama Medical University
Hidaka, Saitama, Japan, 350-1298
2
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan, 104-0045
3
Kyorin University Hospital
Mitaka, Tokyo, Japan, 181-8611