Quantification of ALA-induced PpIX Fluorescence in Patients with Newly Diagnosed or Recurrent Brain Tumors Undergoing Surgery

Status: administratively complete

This phase I trial measures the amount of aminolevulinic acid (ALA)-induced protoporphyrin IX (PpIX) fluorescence in patients with brain tumors that are newly diagnosed or have come back (recurrent) and are undergoing surgery to have them removed. ALA is produced naturally in the body and helps to make the hemoglobin in the blood. As part of this process, ALA is turned into PpIX which glows a reddish-pink color. If extra ALA is drunk a few hours before surgery, more PpIX is produced by tumor cells in brain tumors than is produced by the normal cells in the brain, helping doctors identify tumor cells from normal cells. Fluorescence imaging may help doctors measure the concentrations of PpIX in brain tumor cells and better understand where and how much of the ALA is distributed in the tumor and surrounding tissue.

Inclusion Criteria

Preoperative diagnosis of either presumed first-time low or high grade glioma or recurrent glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme) or metastasis, or meningioma
Tumor judged to be suitable for open cranial resection based on preoperative imaging studies
Valid informed consent by subject or subject’s legally authorized representative (LAR)
No serious associated psychiatric illnesses

Exclusion Criteria

Pregnant women or women who are breast feeding
History of cutaneous photosensitivity, porphyria, hypersensitivity to porphyrins, photodermatosis, exfoliative dermatitis
History of liver disease within the last 12 months
Elevated liver function tests (LFTs) (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase [ALP] or bilirubin levels greater than 2.5 times the normal limit) from laboratory tests conducted within 30 days prior to surgery
Plasma creatinine in excess of 180 umol/L within 30 days prior to surgery
Inability to comply with the photosensitivity precautions associated with the study

PRIMARY OBJECTIVES:

I. To estimate the probability of tumor, P(T), distribution as a function of absolute PpIX concentration, CPpIX, in brain tissue undergoing surgical resection for intracranial tumor with the presumed (presurgical) diagnosis of first-time or recurrent high or low grade glioma, metastasis, or meningioma.

SECONDARY OBJECTIVES:

I. To evaluate the diagnostic accuracy of ALA-induced PpIX fluorescence when (a) quantified on the surgical surface by an intraoperative probe, laparoscope, and wide-field fluorescence imaging system, and (b) detected at depth below the surgical surface by an intraoperative probe, laparoscope, and wide-field fluorescence imaging system.

OUTLINE:

Patients receive aminolevulinic acid hydrochloride orally (PO) 3 hours prior to surgery and then undergo brain tumor resection. During surgery, patients undergo fluorescence imaging to measure PpIX concentrations.

After completion of study, patients are followed up for 30 days.

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Quantification of ALA-induced PpIX Fluorescence in Patients with Newly Diagnosed or Recurrent Brain Tumors Undergoing Surgery

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