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Completed

NCT Number: NCT01167322

Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas

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 single dose of NPC-07 orally, at a dose of 20mg/kg/body weight, 3 hours prior to induction of anaesthesia for surgery of patients with newly or recurrent malignant glioma (WHO grades III/IV).

Positive predictive value will be confirmed by percentage of patients showing positive tumor cell identification in all biopsies taken from areas of strong and weak fluorescence. This study will be divided into two stages. After reviewing of the result of safety and pharmacokinetics of NPC-07 in small number of subjects by independent safety monitoring committee, more subjects will receive NPC-07 in Step II.

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Key information

Conditions

Malignant Glioma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

International Medical Center, Saitama Medical University, Hidaka, Saitama, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NPC-07 for oral administration

Drug

NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.

Other names: 5-ALA, 5-aminolevulic acid hydrochloride

Primary outcomes

  1. Positive predictive value of tissue fluorescence

    Time frame: 1 day

    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.

Secondary outcomes

  1. Quality of fluorescent tissue

    Time frame: 1 day

    Quality of fluorescent tissue by the judgement of the investigator

  2. Positive predictive value of tissue fluorescence in each biopsy tissue sample

    Time frame: 1 day

    Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among all biopsies taken from areas of strong and weak fluorescence.

  3. Percentage of patients without residual tumor

    Time frame: 3 days

    Percentage of patients without residual tumor in the MRI within 72 hours after surgery

  4. Positive predictive value of non-fluorescent tissue at the biopsy level

    Time frame: 1 day

    Positive predictive value of tissue fluorescence at the biopsy level defined as the number of tumor positive biopsies among the non-fluorescent tissue adjacent to fluorescent tissue areas and the tumor distant cortex with respect to tumor (if available).

  5. Sensitivity as percentage of actual positives and specificity as percentage of actual negatives of fluorescence detection at the biopsy level (if available).

    Time frame: 1 day

    Sensitivity as percentage of actual positives(True positive fraction/True positive fraction + False negative fraction)and specificity as percentage of actual negatives of fluorescence detection (True negative fraction/False positive fraction + True negative fraction) at the biopsy level (if available).

  6. Safety

    Time frame: 28 days

    AEs during study period (Day 0 to Day 28), laboratory parameter, vital signs, EKG, pO2

  7. Pharmacokinetic parameters of NPC-07 and active metabolite (Cmax, AUCt, tmax, t1/2）

    Time frame: 2 days

    Pharmacokinetic parameters of 5-ALA and PPVX (Cmax, AUCt, tmax, t1/2）

Sponsors and collaborators

Lead sponsor

Nobelpharma

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2010
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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