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Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

Primary Purpose

Brain Cancer, Brain Tumors, Cancer of Brain

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
5-aminolevulinic acid (5-ALA)
Sponsored by
medac GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Brain Cancer

Eligibility Criteria

18 Years - 72 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma). Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection. First operation of the tumour, no other tumour-specific pretreatment Karnofsky at least 70 % Patient's written informed consent Age 18-72 years Exclusion Criteria: Tumour location in the midline, basal ganglia, cerebellum or brain stem More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases Porphyria, hypersensitivity to porphyrins Renal insufficiency: Creatinine > 2.0 mg/dl Hepatic insufficiency: Bilirubin > 3 mg/dl Quick test < 60 % gamma-GT > 70 U/I Malignancies other than basaliomas Existing or planned pregnancy or lactation, or inadequate contraception Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    5-aminolevulinic acid

    Conventional resection

    Arm Description

    Outcomes

    Primary Outcome Measures

    1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
    2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO).

    Secondary Outcome Measures

    1. Overall survival.
    2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
    3. Volume of residual tumour
    4. Toxicity after oral administration of 5-Aminolevulinic acid.
    5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment

    Full Information

    First Posted
    October 18, 2005
    Last Updated
    April 25, 2012
    Sponsor
    medac GmbH
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00241670
    Brief Title
    Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid
    Official Title
    Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid (5-ALA) vs. Conventional Resection
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    October 1999 (undefined)
    Primary Completion Date
    July 2004 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    medac GmbH

    4. Oversight

    5. Study Description

    Brief Summary
    The aim of the study "Fluorescence-guided resection of malignant gliomas with 5-Aminolevulinic acid (5-ALA) vs. conventional resection" is to determine how accurately contrast agent-accumulating tumour can be removed by primary surgery and to assess the clinical usefulness of this method.
    Detailed Description
    Malignant gliomas are locally invasive tumors that carry a dismal prognosis despite a combination of surgery, radiotherapy and chemotherapy. Cytoreductive surgery is generally considered beneficial but complete resection of contrast enhancing tumor is achieved in less than 20 % of patients, one reason being the difficulty in discerning marginal, enhancing tumor intraoperatively. Five-aminolevulinic acid (5-ALA) leads to the accumulation of fluorescent porphyrins in malignant gliomas, a phenomenon under exploration for intraoperative identification and resection of these tumors. This study investigated the benefit derived from fluorescent-guided resections using 5-ALA on surgical radicality, progression-free survival and morbidity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Cancer, Brain Tumors, Cancer of Brain, Primary Brain Tumors, Brain Tumor, Primary

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    415 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    5-aminolevulinic acid
    Arm Type
    Experimental
    Arm Title
    Conventional resection
    Arm Type
    No Intervention
    Intervention Type
    Drug
    Intervention Name(s)
    5-aminolevulinic acid (5-ALA)
    Intervention Description
    1.5 grams 5-ALA dissolved in 50 ml water, single dose, orally, 2-4 hours prior to surgery
    Primary Outcome Measure Information:
    Title
    1. Percentage of patients with a histologically confirmed malignant glioma (grade III or IV -WHO) without definite residual contrast agent-accumulating tumour in the early post-operative control MRI (within 72 hours of the operation).
    Time Frame
    Within 72 hours after surgery
    Title
    2. Progression-free survival 6 months after primary surgical treatment of a malignant gli-oma in patients with histologically confirmed malignant glioma (grade III or IV -WHO).
    Time Frame
    Within 6 month after surgery
    Secondary Outcome Measure Information:
    Title
    1. Overall survival.
    Time Frame
    Until 18 months after surgery
    Title
    2. Progression-free survival (PFS) 9, 12, 15 and 18 months after primary surgical treatment
    Time Frame
    Until 18 months after surgery
    Title
    3. Volume of residual tumour
    Time Frame
    After surgery
    Title
    4. Toxicity after oral administration of 5-Aminolevulinic acid.
    Time Frame
    Until 18 month after surgery
    Title
    5. Neurological condition 7 days, 6 and 12 weeks, 6, 9, 12, and 18 months after primary surgical treatment
    Time Frame
    Until 18 month after surgery

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    72 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Radiological suspicion of a unilocular malignant glioma with distinct ring- or garland-shaped contrast agent-accumulating tumour structures and a core of reduced intensity in the MRI (central necroses) with no significant non-staining tumour tissue (exclusion of a secondary malignant glioma). Indication for surgical tumour resection. If radical resection is planned, the location of the contrast agent-accumulating tumour should allow complete resection. First operation of the tumour, no other tumour-specific pretreatment Karnofsky at least 70 % Patient's written informed consent Age 18-72 years Exclusion Criteria: Tumour location in the midline, basal ganglia, cerebellum or brain stem More than one contrast agent-accumulating lesion unrelated to the primary tumour or extracerebral metastases Porphyria, hypersensitivity to porphyrins Renal insufficiency: Creatinine > 2.0 mg/dl Hepatic insufficiency: Bilirubin > 3 mg/dl Quick test < 60 % gamma-GT > 70 U/I Malignancies other than basaliomas Existing or planned pregnancy or lactation, or inadequate contraception Simultaneous participation in another clinical trial or participation in another clinical trial in the 30 days preceding randomisation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Hans-Juergen Reulen, MD
    Organizational Affiliation
    Ludwig-Maximilians - University of Munich
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    16648043
    Citation
    Stummer W, Pichlmeier U, Meinel T, Wiestler OD, Zanella F, Reulen HJ; ALA-Glioma Study Group. Fluorescence-guided surgery with 5-aminolevulinic acid for resection of malignant glioma: a randomised controlled multicentre phase III trial. Lancet Oncol. 2006 May;7(5):392-401. doi: 10.1016/S1470-2045(06)70665-9.
    Results Reference
    derived

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    Fluorescence-guided Resection of Malignant Gliomas With 5-Aminolevulinic Acid

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