Tectal Plate GliomaNCT00229814
Study of Brain Tumors (Tectal Tumors) Using Magnetic Resonance Imaging
An observational study of Tectal Plate Glioma, run by Children's Healthcare of Atlanta at 1 site in United States.
Trial summary
Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Read more about this study
- Who is it for?
- Ages 4 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Tectal Plate Glioma
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2005to Dec 2007
- 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 4 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Healthy volunteer children.
Who may be able to join
- patients who are already scheduled for a brain MRI at Children's Healthcare of Atlanta at Scottish Rite for reasons other than tectal plate glioma evaluation
Who cannot join
- patients with tectal plate glioma
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta at Scottish Rite
Atlanta, Georgia, 30342
About this study
Official title: Magnetic Resonance Spectroscopic Analysis of Pediatric Tectal Tumors: Insight Into Pathology and Behavior
Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and spectroscopic features. There is debate whether they truly represent brainstem tumors or whether they are a site of benign cellular overgrowth. The majority of these tumors are pathologically benign and show no or minimal growth. Not all tectal plate tumors, however, have this typically benign course. Some can manifest a more aggressive behavior. There have been reports in the past attempting to analyze the histology and behavior of these tumors. None of the prior series looking at these tumors have included Magnetic Resonance Spectroscopy (MRS) analysis.
It is interesting that according to where tumors occur in the brainstem usually indicates what their histology and behavior is. Although not absolute, we know that tumors can have a very poor prognosis versus an extremely good prognosis depending on their location in the brainstem. Yet there are always the cases that do not act in the typical fashion and this is where MRS can prove helpful.
This study is being done to look at a region of the brain, called the tectal plate, in children. This part of the brain can be involved by tumors. Because of the location of the tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can look at the chemical make up of the brain. MRS may allow us to better understand the nature and behavior of these tumors. However, in order to understand disease in this area, we need to look at the normal chemical make up of the brain in children without tectal plate tumors. Healthy patients are being asked to participate as a normal volunteer. We anticipate having a total of 10 to 12 normal volunteers in the MRS study.
- Conditions
- Tectal Plate Glioma
- Keywords
- Tectal Plate Glioma, Tumor, Brain, MRI, Spectroscopy
- Medical subject headings
- Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionDec 2007
- Study completionDec 2007
Why it stopped: There were technical difficulties and the study was terminated in 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tectal Plate GliomaStudies 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Healthcare of Atlanta
- Sponsor type
- University, hospital or other
- Investigators
- Susan Palasis, M.D., Principal investigator, Children's Diagnostic Imaging of Atlanta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00229814
- Sponsor's protocol ID
- Tectal Tumors MRS
- Status last verified
- Sep 2012
- First submitted
- 12 Sep 2005
- Last updated
- 24 Sep 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Spectroscopic Analysis of Pediatric Tectal Tumors: Insight Into Pathology and Behavior
- ClinicalTrials.gov ID
- NCT00229814
- Acronym / sponsor ID
- Tectal Tumors MRS
- Conditions
- Tectal Plate Glioma
- Keywords
- Tectal Plate Glioma, Tumor, Brain, MRI, Spectroscopy
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: There were technical difficulties and the study was terminated in 2008
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Healthcare of AtlantaUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 30 Sep 2005 (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.
Tectal plate gliomas are relatively rare tumors of childhood with a reported incidence of 10%. Their typical clinical presentation is symptoms and signs of hydrocephalus and are often incidentally diagnosed in the imaging work-up of children with hydrocephalus. Tectal tumors in children comprise a subcategory of brainstem tumors with unique clinical, imaging, and spectroscopic features. There is debate whether they truly represent brainstem tumors or whether they are a site of benign cellular overgrowth. The majority of these tumors are pathologically benign and show no or minimal growth. Not all tectal plate tumors, however, have this typically benign course. Some can manifest a more aggressive behavior. There have been reports in the past attempting to analyze the histology and behavior of these tumors. None of the prior series looking at these tumors have included Magnetic Resonance Spectroscopy (MRS) analysis.
It is interesting that according to where tumors occur in the brainstem usually indicates what their histology and behavior is. Although not absolute, we know that tumors can have a very poor prognosis versus an extremely good prognosis depending on their location in the brainstem. Yet there are always the cases that do not act in the typical fashion and this is where MRS can prove helpful.
This study is being done to look at a region of the brain, called the tectal plate, in children. This part of the brain can be involved by tumors. Because of the location of the tectal plate, it is usually very difficult and risky to get a biopsy (tissue sample) from this area. Magnetic Resonance Spectroscopy (MRS) is a non-invasive imaging technique that can look at the chemical make up of the brain. MRS may allow us to better understand the nature and behavior of these tumors. However, in order to understand disease in this area, we need to look at the normal chemical make up of the brain in children without tectal plate tumors. Healthy patients are being asked to participate as a normal volunteer. We anticipate having a total of 10 to 12 normal volunteers in the MRS study.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 4 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Healthy volunteer children.
Key inclusion criteria (1 listed)
- patients who are already scheduled for a brain MRI at Children's Healthcare of Atlanta at Scottish Rite for reasons other than tectal plate glioma evaluation
Key exclusion criteria (1 listed)
- patients with tectal plate glioma
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2012.
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.
Susan Palasis, M.D. principal investigator
Children's Diagnostic Imaging of Atlanta
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 Tectal Plate Glioma, run by Children's Healthcare of Atlanta 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 24 Sep 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
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 24 Sep 2012.