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5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor

NCT02632370 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 69

Last updated 2019-02-25

No results posted yet for this study

Summary

In support of the US marketing application for 5-ALA, this single arm trial is being conducted to establish the efficacy and safety of Gliolan® (5-ALA) in patients with newly diagnosed or recurrent malignant gliomas. The hypothesis of the study is Gliolan® (5-ALA), as an adjunct to tumor resection, is safe and that real-time tissue fluorescence correlates with malignant histopathology. The primary objective in this single arm study is to define the positive predictive value (PPV) of Gliolan®-induced PPIX fluorescence for malignant tumor at the time of initial resection and first use of FGS by taking a biopsy of tissue presenting with red fluorescence when observed during the course of resection of new or recurrent malignant gliomas. The functionality and performance reliability of the blue light excitation microscope platforms will be assessed.

Conditions

  • Malignant Gliomas

Interventions

DRUG

Gliolan®

single dose of oral 5-ALA (20mg/kg bodyweight) at 3 hours (range 2-5 hours) given preoperatively

PROCEDURE

Fluorescence-Guided Surgery

performed utilizing blue light. At least 3-5 fluorescent tissue samples will be taken.

Sponsors & Collaborators

  • Massachusetts General Hospital

    collaborator OTHER

  • Constantinos Hadjipanayis

    lead OTHER

Principal Investigators

  • Bob Carter, MD, PhD · Massachusetts General Hospital

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2018-12-31
Completion
2018-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT02632370 on ClinicalTrials.gov