5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor
Public ClinicalTrials.gov record NCT02632370. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter Study of 5-Aminolevulinic Acid (5-ALA) to Enhance Visualization of Malignant Tumor in Patients With Newly Diagnosed or Recurrent Malignant Gliomas: A Safety, Histopathology, and Correlative Biomarker Study
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02632370
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 69 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2016 (Type not available)
- Primary completion
- Dec 31, 2018 (Actual)
- Completion
- Dec 31, 2018 (Actual)
- Last update posted
- Feb 25, 2019
2016 – 2018
United States locations
- U.S. sites
- 17
- U.S. states
- 13
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| George Washington University | Washington D.C. | District of Columbia | 20037 | — |
| Delray Medical Center | Delray Beach | Florida | 33484 | — |
| Winship Cancer Institute of Emory University | Atlanta | Georgia | 30322 | — |
| Saint Alphonsus Regional Medical Center | Boise | Idaho | 83706 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| CentraCare St. Cloud Hospital | Saint Cloud | Minnesota | 56303 | — |
| St. Luke's Marion Bloch Neuroscience Institute | Kansas City | Missouri | 64111 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| University of New Mexico School of Medicine, Department of Neurosurgery | Albuquerque | New Mexico | 87131 | — |
| Mount Sinai Beth Israel | New York | New York | 10003 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| St. Luke's University Health Network | Bethlehem | Pennsylvania | 18015 | — |
| Penn State- Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | — |
| Huntsman Cancer Institute | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02632370, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 25, 2019 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02632370 live on ClinicalTrials.gov.