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Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)


Phase 3
18 Years
70 Years
Not Enrolling
Both
Malignant Glioma

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Trial Information

Clinical Study to Assess the Positive Predictive Value of NPC-07 Induced Tissue Fluorescence in Patients With Malignant Glioma (WHO Grades III/IV)


Inclusion Criteria:



- 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 Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Positive predictive value of tissue fluorescence

Outcome Description:

Positive predictive value of tissue fluorescence defined as the percentage of patients showing positive tumor cell identification in all 6 biopsies taken from areas of strong and weak fluorescence.

Outcome Time Frame:

1 day

Safety Issue:

No

Principal Investigator

Soichiro Shibui, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Neurosurgery & Neuro-Oncology Division, National Cancer Center Hospital

Authority:

Japan: Pharmaceuticals and Medical Devices Agency

Study ID:

NPC-07-1

NCT ID:

NCT01167322

Start Date:

August 2010

Completion Date:

December 2011

Related Keywords:

  • Malignant Glioma
  • NPC-07, 5-ALA, photodynamic diagnosis, pharmacokinetics
  • Glioma

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