Epilepsy, Temporal LobeNCT00067418
Light Scattering Spectroscopy to Determine Brain Tumors
An observational study of Epilepsy, Temporal Lobe and Temporal Lobe, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Temporal Lobe, Temporal Lobe
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2003to Oct 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Spectroscopic Determination of Brain Tumor Cells
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.
Read more
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.
Read the detailed description
Optical spectroscopy for detection of brain tumors and tumor margins has been shown to be of use in distinguishing gliomas and metastatic tumor cells from surrounding white matter. Optical spectroscopy has the potential to provide immediate and accurate diagnostic information about the nature and quantity of neoplastic cells, in a minimally-or non-invasive fashion. We propose to use a new method of optical spectroscopy, polarized light-scattering spectroscopy (LSS), which permits discrimination of malignant cancer cells from normal brain cells by virtue of alterations in the cytoplasmic and nuclear ratios of these cells.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s); those with metastatic brain tumor; or patients with medically-refractory temporal lobe epilepsy with a presumed hippocampal source of seizures, who are seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor or normal lateral temporal neocortex resected as part of standard care will be collected at surgery and utilized for research.
- Conditions
- Epilepsy, Temporal Lobe, Temporal Lobe
- Keywords
- Glioma, Brain Tumor, Spectroscopy
- Medical subject headings
- Epilepsy, Temporal Lobe, Glioma, Brain Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2003 (estimated)
- Study startAug 2003
- Study completionOct 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Epilepsy, Temporal LobeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00067418
- Sponsor's protocol ID
- 030270
- Other IDs
- 03-N-0270
- Status last verified
- Oct 2004
- First submitted
- 18 Aug 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
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.
PubMed 11780887Louis 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.
PubMed 12086870Silbergeld 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.
PubMed 9046311
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectroscopic Determination of Brain Tumor Cells
- ClinicalTrials.gov ID
- NCT00067418
- Acronym / sponsor ID
- 030270
- Conditions
- Epilepsy, Temporal Lobe, Temporal Lobe
- Keywords
- Glioma, Brain Tumor, Spectroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Aug 2003
- Study completion
- Oct 2004
- First posted
- 19 Aug 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Optical spectroscopy for detection of brain tumors and tumor margins has been shown to be of use in distinguishing gliomas and metastatic tumor cells from surrounding white matter. Optical spectroscopy has the potential to provide immediate and accurate diagnostic information about the nature and quantity of neoplastic cells, in a minimally-or non-invasive fashion. We propose to use a new method of optical spectroscopy, polarized light-scattering spectroscopy (LSS), which permits discrimination of malignant cancer cells from normal brain cells by virtue of alterations in the cytoplasmic and nuclear ratios of these cells.
Patients suspected of having, or with prior biopsy proof of, a WHO grade II-IV central nervous system (CNS) glial tumor(s); those with metastatic brain tumor; or patients with medically-refractory temporal lobe epilepsy with a presumed hippocampal source of seizures, who are seen in the Surgical Neurology Branch, NINDS, will be considered for entry into this study. Tissue samples of tumor or normal lateral temporal neocortex resected as part of standard care will be collected at surgery and utilized for research.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- Inability to provide informed consent prior to surgery.
- Medical conditions that cannot be corrected prior to surgery that would be standard contraindications for neurosurgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 11780887Lacroix 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.
- Background: PubMed 12086870Louis 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.
- Background: PubMed 9046311Silbergeld 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, Temporal Lobe and Temporal Lobe, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00067418, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008; AzTrials last refreshed its copy on 31 Oct 2026.