NCT00067418

Brief Summary

This study will use light scattering spectroscopy (LSS) to analyze brain tissue removed from patients during brain surgery to determine if this new technology can be used to differentiate between normal and cancerous cells. LSS focuses light on cells or tissues, and the way that light is reflected back from the tissues provides information about the size of cells and the density of the cell nuclei (the part of the cell that contains the genes). Patients between 18 and 75 years of age with a known or suspected brain tumor and patients with temporal lobe epilepsy that does not respond to medication may be eligible for this study. (Examination of tissue from patients with epilepsy will allow comparison of tumor and non-tumor brain cells.) All patients must require surgery to treat their condition. Participants will be admitted to the Clinical Center for 3 to 10 days for physical and neurological examinations, blood and urine tests, and other tests needed to prepare for surgery. They will then undergo surgery. A small amount of tissue removed during surgery for pathological review will be collected for use in this study. Half of the tissue will be examined using LSS to help determine the size of the cell and its nucleus. Studies will be done to measure how many of the cells are actively dividing and which proteins are expressed more often in tumor cells compared with normal cells. This information may shed light on how tumor cells are different from normal cells. Participants may be contacted for up to 3 years to follow their health status.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

August 18, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 19, 2003

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

October 1, 2004

First QC Date

August 18, 2003

Last Update Submit

March 3, 2008

Conditions

Keywords

GliomaBrain TumorSpectroscopy

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Radiographic evidence of primary glial neoplasm of the CNS (WHO grade II-IV) or any patient with a known primary neoplasm of the CNS; patients with a known or with radiographic evidence of resectable metastatic brain tumor(s); or patients with temporal lobe epilepsy (TLE) in whom resective surgery, which will include the lateral termporal neocortex, is indicated.
  • Informed consent from patients age 18 or older.
  • No racial or ethnic group or gender is excluded.
  • Pregnant women who require brain surgery may participate in this study.

You may not qualify if:

  • Inability to provide informed consent prior to surgery.
  • Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Lacroix M, Abi-Said D, Fourney DR, Gokaslan ZL, Shi W, DeMonte F, Lang FF, McCutcheon IE, Hassenbusch SJ, Holland E, Hess K, Michael C, Miller D, Sawaya R. A multivariate analysis of 416 patients with glioblastoma multiforme: prognosis, extent of resection, and survival. J Neurosurg. 2001 Aug;95(2):190-8. doi: 10.3171/jns.2001.95.2.0190.

    PMID: 11780887BACKGROUND
  • Louis DN, Pomeroy SL, Cairncross JG. Focus on central nervous system neoplasia. Cancer Cell. 2002 Mar;1(2):125-8. doi: 10.1016/s1535-6108(02)00040-5. No abstract available.

    PMID: 12086870BACKGROUND
  • Silbergeld DL, Chicoine MR. Isolation and characterization of human malignant glioma cells from histologically normal brain. J Neurosurg. 1997 Mar;86(3):525-31. doi: 10.3171/jns.1997.86.3.0525.

    PMID: 9046311BACKGROUND

MeSH Terms

Conditions

Epilepsy, Temporal LobeGliomaBrain Neoplasms

Condition Hierarchy (Ancestors)

Epilepsies, PartialEpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic SyndromesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by Site

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 18, 2003

First Posted

August 19, 2003

Study Start

August 1, 2003

Study Completion

October 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-10

Locations