Brain TumorsNCT00556153
[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children
An observational study of Brain Tumors, run by Children's Hospital Medical Center, Cincinnati.
Trial summary
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Brain Tumors
- What is being tested?
- [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2013to Feb 2013
- 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 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children ages 5-15 years, with brain tumors
Who may be able to join
- Documented brain tumor at diagnosis or relapse, including high grade glioma, low grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma, ependymoma.
Who cannot join
- Pregnancy
- Requirement for sedation
- Lack of informed consent
About this study
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue.
Read the detailed description
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Tne subjects between ages 5 and 17 years will be studies, to determine if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Drug safety will also be monitored.
- Conditions
- Brain Tumors
- Being tested
- [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical
- Keywords
- brain tumors, children
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceuticalDrug
A single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent.
| Study group | Role | What they receive |
|---|---|---|
| Phase I | Children, ages 5-15 years with brain tumors Receives: Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceutical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios
Measured: 15-30 minutes after IV administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startFeb 2013
- Study completionFeb 2013 (estimated)
Why it stopped: No participants ever enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael J Gelfand, M.D., Principal investigator, Cincinnati Children's Hospital, Cincinnati, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00556153
- Sponsor's protocol ID
- CCHMC IRB# 04-09011
- Status last verified
- Jan 2013
- First submitted
- 7 Nov 2007
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children
- ClinicalTrials.gov ID
- NCT00556153
- Acronym / sponsor ID
- CCHMC IRB# 04-09011
- Conditions
- Brain Tumors
- Keywords
- brain tumors, children
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants ever enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Study start
- Feb 2013
- Study completion
- Feb 2013 (estimated)
- First posted
- 9 Nov 2007 (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.
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue.
Detailed description
The first phase of the study will investigate if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Tne subjects between ages 5 and 17 years will be studies, to determine if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to normal brain tissue. Drug safety will also be monitored.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Phase I | – | Drug: [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceuticalChildren, ages 5-15 years with brain tumors |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children ages 5-15 years, with brain tumors
Key inclusion criteria (1 listed)
- Documented brain tumor at diagnosis or relapse, including high grade glioma, low grade glioma, medulloblastoma including PNET, optic pathway glioma, brainstem glioma, ependymoma.
Key exclusion criteria (3 listed)
- Pregnancy
- Requirement for sedation
- Lack of informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [F-18]Fluoro-DOPA PET, a diagnostic radiopharmaceuticalA single dosage of the diagnostic drug will be administered to individuals who meet inclusion criteria after informed consent. | Drug | Phase I |
Primary outcome
Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios
Time frame: 15-30 minutes after IV administration
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 8 Jan 2013.
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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.
Michael J Gelfand, M.D. principal investigator
Cincinnati Children's Hospital, Cincinnati, OH
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by Children's Hospital Medical Center, Cincinnati.
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 3 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 8 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
Increased uptake of [F-18]FDOPA in pediatric brain tumors compared to contralateral normal brain tissue as measured by standardized uptake value and tumor/non-tumor uptake ratios (time frame: 15-30 minutes after IV administration). It is what the study was designed to measure, not a finding.
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 8 Jan 2013.