Fluorescence Guided Resection of Brain Tumors

NCT00870779 | Completed Phase 1 DMC

• 2 other identifiers: DMS 0711R01NS052274-01A2
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

Removing a tumor from your brain is hard to do because, very often, brain tumors do not have boundaries that are easy for your surgeon to find. In many cases, the surgeon can't tell exactly where the tumor begins or ends. The surgeon usually can remove most of your tumor by looking at the MRI images that were taken of your brain before surgery. However, the surgeon does not have any good way to tell if the entire tumor has been removed or not. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival. It is possible to detect tumor cells by making them glow with a specific color of light (a process called fluorescence). This can be done by having you take the drug, ALA, before your surgery. ALA is a molecule that already exists in the cells of your body. Once enough of it is in your body, it gets converted into another molecule named PpIX. If blue light is shined on a tumor that has enough PpIX, it will glow with red light (fluorescence) that can be detected with a special camera. In this study, we want to determine how the fluorescence (red light) is related to the tumor which appears in the images that are normally taken of your brain (which the surgeon uses to guide the removal of your tumor) and the tumor tissue that will be removed during your surgery. Removing the entire tumor is very important because leaving tumor behind may allow it to grow back which could decrease your chances of survival.

Conditions

Brain Tumors

Keywords

Fluorescence; Brain Tumor; Malignant Glioma; Pituitary Tumor; Skull Base Tumor; Brain Lesions; Brain Metastases; Meningioma

Outcome Measures

Primary Outcomes (1)

• Determine the degree of spatial correlation between local fluorescence recorded intraop and coregistered conventional imaging obtained preop with MR and intraop with ultrasound and operating microscope stereovision.

  From date of first surgery through 6/1/2013

Secondary Outcomes (1)

• Establish the clinical feasibility of integrating FI with conventional image guidance (pMR, iUS and iSV data). Determine the relationships between FI signals, PpIX concentration, histological grade and image features evident for surgical guidance.

  From date of first surgery through 6/1/2013

Study Arms (1)

5-aminolevulinic acid

EXPERIMENTAL

Drug: 5-aminolevulinic acid

Interventions

5-aminolevulinic acid DRUG

20mg/kg 3 hours prior to surgery

Also known as: 5-ALA

5-aminolevulinic acid

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative diagnosis of either presumed low or high grade glioma (astrocytoma, oligodendroglioma, mixed oligo-astrocytoma, anaplastic astrocytoma, and glioblastoma multiforme) or meningioma, pituitary adenoma or metastasis.
• Tumor judged to be suitable for open cranial resection based on preoperative imaging studies.
• Patient able to provide written informed consent.
• Age ≥ 21 years old.

You may not qualify if:

• 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,
• AST, ALT, ALP or bilirubin levels greater than 2.5 times the normal limit at any time during the previous 2 months
• Plasma creatinine in excess of 180 mol/L.
• Inability to comply with the photosensitivity precautions associated with the study
• Patients with an existing DSM-IV Axis 1diagnosis
• Inability to give informed consent

Sponsors & Collaborators

• David W. Roberts: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Glioma; Pituitary Neoplasms; Skull Base Neoplasms; Meningioma

Interventions

Aminolevulinic Acid

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Endocrine Gland Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Skull Neoplasms; Bone Neoplasms; Bone Diseases; Musculoskeletal Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Intervention Hierarchy (Ancestors)

Levulinic Acids; Keto Acids; Carboxylic Acids; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• David W Roberts, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

• Keith Paulsen, PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Surgery (Neurosurgery)

Study Record Dates

• First Submitted: March 25, 2009
• First Posted: March 27, 2009
• Study Start: May 1, 2007
• Primary Completion: July 2, 2012
• Study Completion: July 2, 2013
• Last Updated: June 14, 2019

Record last verified: 2019-06

Locations

US (1)