Recruiting

5-ALA

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT02119338

Conditions

Glioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

5-ala

Study Details

Brief summary:

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.

Conditions

Glioma

Study ID

NCT02119338

Start date

Feb, 2014

Status verified date

Jan, 2017

Completion date

Sep, 2017

Anticipated

Primary completion date

Jun, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

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

Exclusion Criteria

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: 5-ala preoperatively

A dose of 5-ala will be taken by mouth approximately 3 hours before going to surgery.

Interventions

5-ala

dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery.

Primary outcome measure

  • Presence of fluorescence in tumor tissue compared to tissue with treatment effect. [ Time Frame: day of surgery-1 day ]

Central Contacts and Locations

Central contacts

Nader Sanai, MD

602-406-3770Nader.Sanai@bnaneuro.net

Norissa Honea, PhD, RN

602-406-6267Norissa.Honea@dignityhealth.org

Locations

Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Jan 6, 2017

Last verified

Jan, 2017

Keywords

  • 5-ala
  • 5-aminolevulinic acid
  • fluorescence-guided surgery
  • glioma
  • astrocytoma
  • glioblastoma
  • oligodendroglioma
  • recurrence of glioma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2017-01-06.