Tumors of the Central Nervous SystemPhase 1FLTNCT00633958
A Pilot Study of 18F-FLT in Pediatric Patients With Central Nervous System (CNS) Tumors
A Phase 1 study testing 18F-FLT and PET Imaging in people with Tumors of the Central Nervous System, run by Dana-Farber Cancer Institute at 1 site in United States.
Trial summary
In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain tumors relies on the pathologic evaluation of material obtained at the time of the initial operation. Read more about this study
- Who is it for?
- Ages Up to 21 years
- Conditions the study is for
- Tumors of the Central Nervous System
- What is being tested?
- 18F-FLT and PET Imaging
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Mar 2010
- Phase
- Phase 1
- 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 Up to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with newly diagnosed central nervous system tumors undergoing planned surgical resection within 21 days.
- Patients should be < 21 years of age at the time of diagnosis.
- Patients should be capable of achieving imaging without the need for sedation or anesthesia.
- Karnofsky Performance Status ≥ 50. For infants, the Lansky play scale ≥ 50% can be substituted.
- Patients must not be pregnant or nursing.
- Signed Informed Consent.
- Patients receiving steroids and/or anti-seizure medications are eligible for this study.
Who cannot join
- Prior radiation therapy and/or chemotherapy are not permitted.
- Active infection
- Pregnancy or breast feeding
- Serious concurrent medical illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: A Pilot, Non-Therapeutic NeuroImaging Study of 18F-FLT in Pediatric Patients With Newly Diagnosed Central Nervous System Tumors
In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain tumors relies on the pathologic evaluation of material obtained at the time of the initial operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade lesions due to their increased glucose metabolism, the high tracer uptake of the normal adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a new imaging agent that has two significant advantages in the imaging of CNS tumors. First, this agent detects cellular proliferation directly, and second, the normal brain does not take up the agent, making a positive area(s) easy to identify. Before embarking on a large pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients, the investigators are proposing a limited patient pilot study to evaluate the biodistribution, dosimetry and specificity of this compound when compared to immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing surgical resection.
Read the detailed description
Patients will undergo standard pre-diagnostic imaging of the sites of disease using standard MRI techniques. If disease is suspected in both the brain and spine, then both imaging modalities should be obtained. This imaging should be obtained no more than 21 days before surgical resection. As close as possible to the completion of the MRI scans, patients will undergo 18F-FLT imaging using a single administration of tracer, and PET image acquisition at four different time points (baseline, 1 hr post injection, 2 hrs post injection and 4-6 hours post injection). A whole body PET scan (top of the head to mid thigh) will be performed immediately after injection (PET acquisition #1). These data will be acquired with a 2 minute emission and a 2 minute transmission scan at each bed position. Following this acquisition, the subject will empty his or her bladder. At 45 minutes post-injection, a brain and/or spine (body) PET scan will be acquired with a 10 min emission scan and a 5 min transmission scan (PET acquisition #2). This scan will include all areas of suspected tumor (brain, spine, or brain and spine). Following PET acquisition #2, a whole body PET scan will be acquired according to the same protocol as above (PET acquisition #3). If possible, a final whole body scan will be acquired 4-6 h post-injection (PET acquisition #4). All PET acquisitions will be acquired in 3D mode and reconstructed with the FORE re-binned OSEM algorithm with measured attenuation correction. Blood samples will be obtained at the completion of each whole body scan. Patients will receive the dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Patients will then undergo maximal surgical resection. Pieces from different areas of the tumor will be marked for correlation to imaging studies when possible. Tumor samples will undergo standard immunohistochemical analysis for cellular activation including mitotic index and MIB-1 proliferation staining.
Serial blood draws will also be obtained at four different time points (baseline, 1 hr post injection, 2 hrs post injection, and 4-6 hours post injection) to evaluate clearance of 18F-FLT from the blood.
For the biodistribution, the 3D regions of interest (ROIs) will be drawn about each major organ that is identified on the whole body scans. This will be performed on each of the whole body scans and a time activity curve will be generated. The residence time for each organ will be determined. The blood data will be pipetted and counted for estimates of activity in the blood and bone marrow. For the brain and/or spine images, the PET data will be registered to the subjects' MRI. The PET scan will be graded on a subjective 4-point scale. 3D ROIs will be drawn around the tumor. In addition, an analogous ROI will be drawn in normal brain background and about the whole brain for comparison. For the tumor, tumor-to-background, tumor-to-whole brain ratios will be determined. In addition, standard uptake values (SUVs) will be determined for the tumor and background.
- Conditions
- Tumors of the Central Nervous System
- Being tested
- 18F-FLT, PET Imaging
- Keywords
- 18F-FLT, FLT, PET, CNS tumors, Newly, diagnosed
- Medical subject headings
- Central Nervous System Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
18F-FLTDrug
Also called 18F]-Fluorothymidine
Patients will receive a dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Dosing will be based on age.
PET ImagingRadiation
| Study group | Role | What they receive |
|---|---|---|
| 18F-FLT | Experimental | All subjects will receive 18F-FLT prior to PET imaging. Receives: Drug: 18F-FLT; Radiation: PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the distribution, localization and kinetics of localization of 18F-FLT in pediatric patients with central nervous system tumors
Measured: Assessed shortly after subjects undergo neuroimaging
Secondary outcomes (1)
To correlate the activity of administering 18F-FLT in newly diagnosed pediatric brain tumor patients to standard immunohistochemical markers of cellular activation and MRI imaging
Measured: Assessed shortly after subjects undergo neuroimaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: Large phase II opened to accue same patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumors of the Central Nervous SystemStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital
- Responsible party
- Sponsor
- Investigators
- Mark Kieran, MD, Principal investigator, Dana-Farber Cancer Institute/Children's Hospital Boston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633958
- Sponsor's protocol ID
- 05-303
- Acronym
- FLT
- Status last verified
- Oct 2021
- First submitted
- 5 Mar 2008
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Non-Therapeutic NeuroImaging Study of 18F-FLT in Pediatric Patients With Newly Diagnosed Central Nervous System Tumors
- ClinicalTrials.gov ID
- NCT00633958
- Acronym / sponsor ID
- FLT / 05-303
- Conditions
- Tumors of the Central Nervous System
- Keywords
- 18F-FLT, FLT, PET, CNS tumors, Newly, diagnosed
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Large phase II opened to accue same patients
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Boston Children's Hospital
- Study start
- Mar 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Mar 2008 (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.
In spite of numerous advances in neuroimaging techniques, the diagnosis of pediatric brain tumors relies on the pathologic evaluation of material obtained at the time of the initial operation. While 18F-FDG-positron emission tomography (PET) helps identify higher-grade lesions due to their increased glucose metabolism, the high tracer uptake of the normal adjacent brains makes this modality of limited value. Fluorine-18 fluorothymidine (FLT) is a new imaging agent that has two significant advantages in the imaging of CNS tumors. First, this agent detects cellular proliferation directly, and second, the normal brain does not take up the agent, making a positive area(s) easy to identify. Before embarking on a large pediatric disease stratified assessment of FLT imaging in pediatric neurooncology patients, the investigators are proposing a limited patient pilot study to evaluate the biodistribution, dosimetry and specificity of this compound when compared to immunohistochemical assessment of mitotic activity in newly diagnosed patients undergoing surgical resection.
Detailed description
Patients will undergo standard pre-diagnostic imaging of the sites of disease using standard MRI techniques. If disease is suspected in both the brain and spine, then both imaging modalities should be obtained. This imaging should be obtained no more than 21 days before surgical resection. As close as possible to the completion of the MRI scans, patients will undergo 18F-FLT imaging using a single administration of tracer, and PET image acquisition at four different time points (baseline, 1 hr post injection, 2 hrs post injection and 4-6 hours post injection). A whole body PET scan (top of the head to mid thigh) will be performed immediately after injection (PET acquisition #1). These data will be acquired with a 2 minute emission and a 2 minute transmission scan at each bed position. Following this acquisition, the subject will empty his or her bladder. At 45 minutes post-injection, a brain and/or spine (body) PET scan will be acquired with a 10 min emission scan and a 5 min transmission scan (PET acquisition #2). This scan will include all areas of suspected tumor (brain, spine, or brain and spine). Following PET acquisition #2, a whole body PET scan will be acquired according to the same protocol as above (PET acquisition #3). If possible, a final whole body scan will be acquired 4-6 h post-injection (PET acquisition #4). All PET acquisitions will be acquired in 3D mode and reconstructed with the FORE re-binned OSEM algorithm with measured attenuation correction. Blood samples will be obtained at the completion of each whole body scan. Patients will receive the dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Patients will then undergo maximal surgical resection. Pieces from different areas of the tumor will be marked for correlation to imaging studies when possible. Tumor samples will undergo standard immunohistochemical analysis for cellular activation including mitotic index and MIB-1 proliferation staining.
Serial blood draws will also be obtained at four different time points (baseline, 1 hr post injection, 2 hrs post injection, and 4-6 hours post injection) to evaluate clearance of 18F-FLT from the blood.
For the biodistribution, the 3D regions of interest (ROIs) will be drawn about each major organ that is identified on the whole body scans. This will be performed on each of the whole body scans and a time activity curve will be generated. The residence time for each organ will be determined. The blood data will be pipetted and counted for estimates of activity in the blood and bone marrow. For the brain and/or spine images, the PET data will be registered to the subjects' MRI. The PET scan will be graded on a subjective 4-point scale. 3D ROIs will be drawn around the tumor. In addition, an analogous ROI will be drawn in normal brain background and about the whole brain for comparison. For the tumor, tumor-to-background, tumor-to-whole brain ratios will be determined. In addition, standard uptake values (SUVs) will be determined for the tumor and background.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 18F-FLT | Experimental | Drug: 18F-FLT, Radiation: PET ImagingAll subjects will receive 18F-FLT prior to PET imaging. |
Who may qualify
- Ages
- Up to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Pediatric patients with newly diagnosed central nervous system tumors undergoing planned surgical resection within 21 days.
- Patients should be < 21 years of age at the time of diagnosis.
- Patients should be capable of achieving imaging without the need for sedation or anesthesia.
- Karnofsky Performance Status ≥ 50. For infants, the Lansky play scale ≥ 50% can be substituted.
- Patients must not be pregnant or nursing.
Key exclusion criteria (4 listed)
- Prior radiation therapy and/or chemotherapy are not permitted.
- Active infection
- Pregnancy or breast feeding
- Serious concurrent medical illness
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 |
|---|---|---|
| 18F-FLTAlso: 18F]-FluorothymidinePatients will receive a dose of 18F-FLT through a fresh intravenous catheter as per standard PET procedures. Dosing will be based on age. | Drug | 18F-FLT |
| PET Imaging | Radiation | 18F-FLT |
Primary outcome
To determine the distribution, localization and kinetics of localization of 18F-FLT in pediatric patients with central nervous system tumors
Time frame: Assessed shortly after subjects undergo neuroimaging
1 secondary outcome
To correlate the activity of administering 18F-FLT in newly diagnosed pediatric brain tumor patients to standard immunohistochemical markers of cellular activation and MRI imaging
Time frame: Assessed shortly after subjects undergo neuroimaging
Results and safety
The study was stopped early (reason given: Large phase II opened to accue same patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
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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.
Mark Kieran, MD principal investigator
Dana-Farber Cancer Institute/Children's Hospital Boston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 18F-FLT and PET Imaging in people with Tumors of the Central Nervous System, run by Dana-Farber Cancer Institute 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 7 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Oct 2021. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Large phase II opened to accue same patients). Results are not available in the source record.
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?
To determine the distribution, localization and kinetics of localization of 18F-FLT in pediatric patients with central nervous system tumors (time frame: Assessed shortly after subjects undergo neuroimaging). 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 20 Oct 2021.