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Trial record 13 of 23 for:    cancer | Studies received from 04/22/2016 to 04/22/2016

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

This study has been completed.
Sponsor:
Collaborator:
IKP
Information provided by (Responsible Party):
medac GmbH
ClinicalTrials.gov Identifier:
NCT02755142
First received: April 22, 2016
Last updated: May 20, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Brain Neoplasm Biological: Gliolan Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Clinical Phase I/II Study on 5-aminolevulinic Acid Hydrochloride (5-ALA) for Fluorescence-guided Resection of Malignant Gliomas

Resource links provided by NLM:


Further study details as provided by medac GmbH:

Primary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: February 2000
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Dose level 1
0,2 mg/Kg
Biological: Gliolan
Other Name: 5-Aminolevulinic Acid Hydrochloride (5-ALA)
Active Comparator: Dose level 2
2,0 mg/Kg
Biological: Gliolan
Other Name: 5-Aminolevulinic Acid Hydrochloride (5-ALA)
Active Comparator: Dose level 3
20 mg/Kg
Biological: Gliolan
Other Name: 5-Aminolevulinic Acid Hydrochloride (5-ALA)

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Responsible Party: medac GmbH
ClinicalTrials.gov Identifier: NCT02755142     History of Changes
Other Study ID Numbers: MC-ALS.8-I/GLI
Study First Received: April 22, 2016
Last Updated: May 20, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Brain Neoplasms
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Glioma
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on August 18, 2017