Clinical Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

May 20, 2016 updated by: medac GmbH

Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

This study is planned to detect a dose-efficacy relationship between the chosen dose levels of MC506/1 and the extent and quality of fluorescence in the tumour core in patients with newly diagnosed malignant glioma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 2
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Radiological suspicion of a malignant glioma with distinct ring- or garland shaped, contrast agent-enhancing tumour structures and a core area of reduced intensity in the MRI (tumour necrosis)
  • Indication for surgical tumour resection
  • First operation of the tumour, no other tumour-specific pre-treatment
  • Karnofsky Performance Scale 70%
  • Patient's written informed consent
  • Age 18-75 years

Exclusion Criteria:

  • Porphyria, hypersensitivity to porphyrins

  • Renal insufficiency:

    • Creatinine > 2.0 mg/dl

  • Hepatic insufficiency:

    • Bilirubin > 3 mg/dl
    • Quick test < 60 %
    • GT > 100 U/I
  • Other known malignancy (except basaliomas)

Women:

  • Existing/planned pregnancy (to be checked by a pregnancy test if of child-bearing age)/lactation or inadequate contraception (hormone cycle regulation pill or condom)

Men:

  • Inadequate contraception (condom)
  • Dementia or mental condition making it impossible to understand the therapy and therefore prohibiting written consent
  • Simultaneous participation or participation in another clinical trial in the preceding 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dose level 1
0,2 mg/Kg
Biological: Gliolan
Other Names:
  • 5-Aminolevulinic Acid Hydrochloride (5-ALA)
Active Comparator: Dose level 2
2,0 mg/Kg
Biological: Gliolan
Other Names:
  • 5-Aminolevulinic Acid Hydrochloride (5-ALA)
Active Comparator: Dose level 3
20 mg/Kg
Biological: Gliolan
Other Names:
  • 5-Aminolevulinic Acid Hydrochloride (5-ALA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of a dose-efficacy relationship between the dose levels and the extent and quality of fluorescence in the tumour core (of newly diagnosed malignant glioma).
Time Frame: Within 3 hours
After completion of resection, global fluorescence extent in the tumour core will be assessed by the first and second surgeon. It will be estimated whether approx. 0/3, 1/3, 2/3 or 3/3 of the tumour core is identified using standard white operation light were fluorescent (irrespective of fluorescence quality). The global quality of Gliolan induced tissue fluorescence within the tumour core will be recorded as being strong, weak or missing. As an objective control of the subjective assessment of the fluorescent quality, selected areas will be measured spectrometrically.
Within 3 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

medac GmbH

Collaborators

IKP

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2000

Primary Completion (Actual)

June 1, 2001

Study Completion (Actual)

June 1, 2001

Study Registration Dates

First Submitted

April 22, 2016

First Submitted That Met QC Criteria

April 26, 2016

First Posted (Estimate)

April 28, 2016

Study Record Updates

Last Update Posted (Estimate)

May 23, 2016

Last Update Submitted That Met QC Criteria

May 20, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MC-ALS.8-I/GLI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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