5-ALA in Recurrent Glioma

Status unconfirmed · Not applicable

Conditions studied: Glioma

In brief

The investigators propose a single-center, non-randomized, single-arm study at the Barrow Neurological Institute/St. Joseph's Hospital for recurrent glioma. The 5-ALA for recurrent glioma study will correlate presence of fluorescence in tumor tissue with pathological findings. This will be done using three cohorts in dose escalation. The investigators' hypothesis is that (for both low- and high-grade gliomas,) a lower dose of 5-ALA will result in less false positive fluorescence.

Key facts

Study ID

NCT02119338

Run by

St. Joseph's Hospital and Medical Center, Phoenix

People needed

60

Starts

2014-02-01

Expected to finish

2017-09-01

Last updated by the study team

2017-01-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Presumed recurrent glioma
• Age > 18 years
• Normal bone marrow function (WBC > 3000, Platelets > 100,000)

You may not qualify if…

• Pregnancy
• History of photosensitivity, porphyria, or exfoliative dermatitis
• Hepatic dysfunction in the last 12 months [defined by aspartate aminotransferase(AST), alanine aminotransferase (ALT) , alkaline phosphatase (ALP) , bilirubin > 2.5 x normal]
• Serum creatinine > 180 µmol/L
• Estimated Glomerular Filtration Rate (eGFR)< 60 ml/min/1.73m2
• Inability to undergo MRI with contrast

Where it is running

• Barrow Neurological Institute at St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States (enrolling)

Full record on ClinicalTrials.gov

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