A Phase 1/2 interventional study of Gliolan in Brain Neoplasm, sponsored by medac GmbH. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-23.
Sponsored by medac GmbH · Phase 1/2 and Interventional
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.
1,993 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.
This study's enrollment of 21 is below the median of 40 across 1,479 interventional studies indexed under Brain Neoplasms.
Browse Brain Neoplasms studies →medac GmbH is the lead sponsor of 22 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Renal insufficiency:
Hepatic insufficiency:
Women:
Men:
0,2 mg/Kg
Biological: Gliolan
2,0 mg/Kg
Biological: Gliolan
20 mg/Kg
Biological: Gliolan
Drug pages: Aminolevulinic Acid · Oral Aminolevulinic Acid Hydrochloride
Also known as: 5-Aminolevulinic Acid Hydrochloride (5-ALA)
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).
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.
Time frame: Within 3 hours
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
The record gives a start of Feb 2000, a primary completion of Jun 2001 and a completion of Jun 2001. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aminolevulinic Acid · Oral Aminolevulinic Acid Hydrochloride