Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
MultiCare Health System Research Institute
This is a Phase 2 study and all subjects will receive open label Aminolevulinic Acid in a dose of 20mg/kg given orally 3 hours prior to surgery. Brain tumors will be resected with the aid of ultraviolet light to visualize the tumor. After surgery an MRI will be done to determine whether the tumor has been completely or partially resected. All subjects will be followed for safety. All subjects will be followed closely by clinical examination and by MRI to monitor for disease recurrence.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Clinically documented primary brain tumor for which surgical resection is indicated.
Age 18 years and older.
ECOG Performance status less than or equal to 2.
Laboratory values as follows:
Leukocytes greater than or equal to 3,000. ANC greater than or equal to 1,500. Platelets greater than or equal to 100,000. Total Bilirubin WNL. AST/ALT less than or equal to 2.5 times ULN. Creatinine WNL. or Creatinine Clearance greater than or equal to 60ml/min/1.73m2 if SCr above institutional normal.
Ability to provide informed consent or consent from a Legally Authorized Representative.
You may not be if
Receipt of an investigational agent within 30 days.
Allergy to ALA or similar compounds.
Personal or family history of porphyria.
Uncontrolled intercurrent illness.
Inability to comply with the protocol.
Pregnancy, breastfeeding.
Clareo Health | A Study of Aminolevulinic Acid Used to Enhance Visualization and Surgical Removal of Brain Tumors
