Brain NeoplasmsPhase 2NCT01244737

FLT-PET Imaging of Brain Tumors in Children

A Phase 2 study testing [18F] FLT in people with Brain Neoplasms, run by Frederick Daniel Grant at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages Up to 21 years
Conditions the study is for: Brain Neoplasms
What is being tested?: [18F] FLT
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: Oct 2010to 5 Feb 2023
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

age 21 years or less
capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
Patients receiving steroids and/or anti-seizure medications are eligible

Who cannot join

clinically active infection
pregnancy or breast-feeding
serious intercurrent medical illness
require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging

Trial locations and contacts

1 site in 1 country.

United States1 site

Children's Hospital, Boston
Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children

Brain tumors are the leading cause of death from solid tumors in children. Tumor imaging is important in the management of these tumors, but current imaging methods have limitations in providing the necessary information for optimal treatment of these patients. The goal of this study is to evaluate the potential utility of positron emission tomography (PET) with 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) in the medical management of brain tumors in children. Funding source - FDA Office of Orphan Product Development (OOPD)

Read the detailed description

Although pediatric central nervous system tumors are rare, they are a significant contributor to morbidity and mortality in children. Tumor staging, detecting recurrent tumor, and assessing the response to therapy are critical in the treatment of brain tumors, but current imaging methods have major limitations in providing such information. The objective of this study is to validate 3'-deoxy-3'-[F-18] fluorothymidine (18F-FLT) as a measure of tumor proliferation and to demonstrate the utility of 18F-FLT as a PET imaging agent in children with central nervous system tumors. The proposed studies will evaluate 18F-FLT PET in three groups:

Children with a new diagnosis of central nervous system tumor.
Children in whom conventional imaging has raised concern for possible recurrence of a central nervous system tumor.
Children receiving post-operative chemotherapy for a central nervous system tumor.

In these three groups, correlation of 18F-FLT uptake with tumor histopathology and patient outcome will be used to assess the utility of 18F-FLT for grading tumors at diagnosis, for accurate identification of tumor recurrence, and for early assessment of the response to chemotherapy.

Conditions: Brain Neoplasms
Being tested: [18F] FLT
Keywords: Brain neoplasms, Children, Positron-Emission Tomography, 18F-FLT
Medical subject headings: Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

[18F] FLTDrug
Also called 3'-deoxy-3'-[F-18] fluorothymidine, [18F] fluorothymidine
[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan

Study groups in NCT01244737
Study group	Role	What they receive
New diagnosis of brain tumor	Experimental	In children with a new diagnosis of central nervous system tumor, a PET scan will be performed using [18F] FLT. Receives: Drug: [18F] FLT
Possible recurrent brain tumor	Experimental	In children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using [18F] PET. Receives: Drug: [18F] FLT
Brain tumor response to chemotherapy	Experimental	In children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using [18F] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment. Receives: Drug: [18F] FLT

What is being measured

The primary outcome is the main question the study is designed to answer.

[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation
[18F] FLT uptake, as determined by pre-operative positron emission tomography (PET) imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor. This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.
Measured: on average 1 week
MIB Positive (Percent)
On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining
Measured: 30 days

Secondary outcomes (2)

Biodistribution of [18F]FLT
The distribution, localization, and kinetics of localization of [18F] FLT will be assessed by FLT-PET in 12 subjects.
Measured: 6 hours
Preliminary Evaluation of Clinical Utility of [18F] FLT PET
In individuals with a diagnosed primary brain tumor in whom therapy will include chemotherapy,.[18F] FLT uptake, as determined by positron emission tomography (PET) imaging, will assessed before and after two cycles of chemotherapy. Response will be determined by comparing the FL uptake before and after therapy.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 20105 Feb 2023

First posted19 Nov 2010 (estimated)
Study startOct 2010
Primary completion5 Feb 2023
Study completion5 Feb 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Brain NeoplasmsStudies 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: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01244737
Sponsor's protocol ID: IND 104365
Other IDs: R01FD003718
Status last verified: Jun 2024
First submitted: 29 Oct 2010
Last updated: 11 Jul 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: No current plans to share individual participant data

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase 2 Study of [18F]FLT for PET Imaging of Brain Tumors in Children
ClinicalTrials.gov ID: NCT01244737
Acronym / sponsor ID: IND 104365
Conditions: Brain Neoplasms
Keywords: Brain neoplasms, Children, Positron-Emission Tomography, 18F-FLT
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Frederick Daniel GrantUniversity, hospital or other
Collaborators: Dana-Farber Cancer Institute
Study start: Oct 2010 (actual)
Primary completion: 5 Feb 2023 (actual)
Study completion: 5 Feb 2023 (actual)
First posted: 19 Nov 2010 (estimated)
Results: Posted 11 Jul 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Children with a new diagnosis of central nervous system tumor.
Children in whom conventional imaging has raised concern for possible recurrence of a central nervous system tumor.
Children receiving post-operative chemotherapy for a central nervous system tumor.

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
New diagnosis of brain tumor	Experimental	Drug: [18F] FLTIn children with a new diagnosis of central nervous system tumor, a PET scan will be performed using [18F] FLT.
Possible recurrent brain tumor	Experimental	Drug: [18F] FLTIn children in whom there is concern for recurrent central nervous system tumor, a PET scan will be performed using [18F] PET.
Brain tumor response to chemotherapy	Experimental	Drug: [18F] FLTIn children with a newly diagnosed central nervous system tumor who will be treated with post-operative chemotherapy, a PET scan will be performed using [18F] FLT before the start and after two cycles of chemotherapy. Despite much effort and working with referring physicians at multiple hospitals, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.

Who may qualify

Ages: Up to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

age 21 years or less
capable of achieving imaging without need for sedation or anesthesia (typically age 8 years or greater, but there is no lower limit for age for eligibility)
Karnofsky Performance Status of 50 or greater in subjects age 12 years or greater, for age less than 12 years a Lansky play scale of 50% or greater
Patients receiving steroids and/or anti-seizure medications are eligible

Key exclusion criteria (4 listed)

clinically active infection
pregnancy or breast-feeding
serious intercurrent medical illness
require emergency surgical intervention that would be inappropriately delayed by FLT-PET imaging

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: 3'-deoxy-3'-[F-18] fluorothymidine, [18F] fluorothymidine[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan	Drug	Brain tumor response to chemotherapy, New diagnosis of brain tumor, Possible recurrent brain tumor

Primary outcome

[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation
Time frame: on average 1 week
[18F] FLT uptake, as determined by pre-operative positron emission tomography (PET) imaging, will be compared to histological markers of cellular proliferation in the resected brain tumor. This will be performed in three groups of subjects (3 arms): (1)children with newly diagnosed central nervous system tumors, (2) children in whom there is concern for recurrence of central nervous system tumor,(3) children with central nervous system tumors that are treated with post-operative chemotherapy.
MIB Positive (Percent)
Time frame: 30 days
On pathological specimens, tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining

2 secondary outcomes

Biodistribution of [18F]FLT
Time frame: 6 hours
Preliminary Evaluation of Clinical Utility of [18F] FLT PET
Time frame: 3 months

Results and safety

Results posted to the registry on 11 Jul 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
New Diagnosis of Brain Tumor	16	8
Possible Recurrent Brain Tumor	28	5
Brain Tumor Response to Chemotherapy	6	0

Primary outcome: [18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation

Time frame: on average 1 week. Mean (Full Range). Unit: SUV max

Measure	New Diagnosis of Brain Tumor n = 8	Possible Recurrent Brain Tumor n = 5
Value	1.57 (0.12 to 4.00)	3.00 (1.54 to 4.00)

New Diagnosis of Brain Tumor vs Possible Recurrent Brain Tumor: Pearson correlation co-efficient: 0.80, p < 0.001, Regression, Linear

Population analysed: Participants were evaluable if brain tumor surgery was performed within 30 days of the FLT-PET scan, if surgical pathology confirmed the diagnosis of brain tumor, and the results of tissue immunohistology were available. On the brain PET scan, tumor uptake of FLT was assessed by SUVmax, the standard clinical measure of tracer uptake, and tumor proliferation was assessed as the fraction of cells with positive MIB immunostaining

Primary outcome: MIB Positive (Percent)

Time frame: 30 days. Mean (Full Range). Unit: percent positive cells

Measure	New Diagnosis of Brain Tumor n = 8	Possible Recurrent Brain Tumor n = 5
Value	17.3 (0.9 to 59.4)	32.8 (4.3 to 89)

Population analysed: Participants in Arm 3 (Brain tumor response to chemotherapy) were not expected to undergo surgery during their chemotherapy. Therefore, they did have FLT-PET, but no assessment for tumor proliferation (percent MIB positive) was performed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 week. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
New Diagnosis of Brain Tumor	0 of 16 (0%)	1 of 16 (6.3%)	0 of 16
Possible Recurrent Brain Tumor	2 of 28 (7.1%)	3 of 28 (10.7%)	0 of 28
Brain Tumor Response to Chemotherapy	0 of 6 (0%)	0 of 6 (0%)	0 of 6

Limitations and caveats (from the sponsor): Arm 3: Despite much recruitment effort, enrollment in this arm remained low, and it seemed unlikely that meaningful enrollment would be accomplished. A revised study plan was submitted to the granting agency and FDA, and this arm was closed to further enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. No current plans to share individual participant data

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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.

Frederick D Grant, MD principal investigator

Children's Hospital, Boston, Harvard Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing [18F] FLT in people with Brain Neoplasms, run by Frederick Daniel Grant 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 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: finished, as of the sponsor's last update on 11 Jul 2024. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

[18F] Fluorothymidine ([18F]-FLT) Uptake as a Marker of Cellular Proliferation (time frame: on average 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01244737.

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 11 Jul 2024.