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Imaging Procedure Using ALA in Finding Residual Tumor in Grade IV Malignant Astrocytoma

NCT00752323 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2021-09-17

No results posted yet for this study

Summary

RATIONALE: Imaging procedures that use aminolevulinic acid (ALA) may help find and diagnose residual tumor in participants with grade IV malignant astrocytoma who are undergoing surgery to remove the tumor.

PURPOSE: Our primary long-term goal is to improve the completeness of surgical resection of malignant brain tumor through image- guided fluorescence localization. We hypothesize that the use of qualitative fluorescence imaging and point PpIX concentration quantification will enable more complete tumor resection than normal direct (i.e., white light) visualization, and thereby improve participant survival.

Conditions

Interventions

DRUG

aminolevulinic acid

Given orally

PROCEDURE

Surgical Resection

Surgical resection - 6 biopsies from 3 fluorescent regions

Sponsors & Collaborators

  • Andrew Sloan, MD

    lead OTHER

Principal Investigators

  • Andrew Sloan, MD · University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-08
Primary Completion
2018-09-15
Completion
2018-10-14
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00752323 on ClinicalTrials.gov