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Clinical trialNCT00977795WithdrawnPhase 1/PHASE2Interventional

A Study of the Specificity and Sensitivity of 5-ALA Fluorescence in Malignant Brain Tumors

SponsorEndeavor HealthEnrollment0Brain Neoplasms
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Extent of resection is a very important prognostic factor affecting survival in individuals diagnosed with a malignant glioma. However, the infiltrative nature of the malignant glioma tumor cells produces indistinct borders between normal and malignant tissues, and the lack of easily identifiable tumor margins confounds attempts at total resection. The investigators propose to identify the borders of malignant gliomas intraoperatively using oral 5-aminolevulinic Acid (5-ALA) which results in fluorescence of the malignant cells and thereby provide an opportunity for more complete tumor resection. When exogenous 5-ALA is provided at increased concentration the tumor cells will become fluorescent under ultraviolet light. This feature identifies the tumor cells intraoperatively and facilitates complete resection. The following data will be collected: * Dose-limiting toxicity data * Tumor fluorescence assessed by neurosurgeon (0 to +++) in three distinct areas of fluorescence (Strong fluorescence, Weak fluorescence, No fluorescence) * Tumor density from biopsies obtained by the neurosurgeon in the same three distinct areas of fluorescence and assessed by neuropathology (Solid tumor, Tumor mixed infiltrating normal brain, No tumor) * Neurosurgeon's intra-operative estimate of residual tumor * Neuroradiologist's estimate of post-operative residual tumor on MRI * Time to progression by MRI * Survival (time to progression, one year survival rate and total survival This trial will evaluate: * The toxicity of a single dose of oral 5-ALA given pre-operatively. * The sensitivity and specificity of 5-ALA - Protoporphyrin IX (Pp IX) as an intraoperative fluorescent detection agent and aid for resection of tumor tissue remaining in the walls of the resection cavity of primary and recurrent malignant brain tumors. * The relationship of the neurosurgeon's estimate of the extent of malignant glioma resection (as guided by tumor fluorescence) to the actual extent of resection determined by post-operative imaging. * The time-to-progression, one year survival rate and total survival as a function of the extent of resection. Following completion of the phase 1 portion of this trial, an additional 15 subjects will be entered at the recommended phase 2 dose level in order to further define the above parameters at the recommended phase 2 dose level.

Investigators

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Sites

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Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

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Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
30 Sept 2009
Primary completion
31 Jan 2010
Completion
31 Jan 2010
Last update posted
10 Sept 2019
Registered enrollment
0
Registry id
NCT00977795

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.