Pediatric Brain TumorsEarly Phase 1NCT03451123
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
A Early Phase 1 study testing FET PET/MRI in people with Pediatric Brain Tumors, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary objectives of this study are: 1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone. 2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Pediatric Brain Tumors
- What is being tested?
- FET PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 29 Aug 2023
- Phase
- Early 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.
- Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.
- Patient must be 18 years of age or younger at the time of study enrollment.
- Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
- Patient must have a life expectancy greater than 8 weeks.
- Patient must be able to undergo FET-PET/MRI without sedation.
- Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing.
Who cannot join
- Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
- Patient must not have received radiation therapy within the past 6 months.
- Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
- Patient must not be pregnant or breast feeding.
- Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
- Patients must not have a history of brain metastases.
Trial locations and contacts
1 site in 1 country.
United States1 site
UAB Advanced Imaging Facility
Birmingham, Alabama, 35294
About this study
The primary objectives of this study are:
- Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone.
- Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.
A secondary objective of this study is:
- Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.
- Conditions
- Pediatric Brain Tumors
- Being tested
- FET PET/MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FET PET/MRIDrug
FET PET/MRI scan before and after surgery
| Study group | Role | What they receive |
|---|---|---|
| FET-PET/MRI | Experimental | O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI Receives: Drug: FET PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients whose surgical plan change with FET-PET/MRI compared to MRI alone.
Surgical planning will be performed prior to brain tumor resection based on MRI alone and then with FET-PET/MRI. The surgical margins will be compared and the percentage of patients whose surgical plans change with FET-PET/MRI will be calculated.
Measured: 2 years
Percentage of patients who have residual tumor after surgery detected with FET-PET/MRI
The percentage of patients with residual tumor identified with FET-PET/MRI will be measured. This percentage will be compared to detection of residual tumor by MRI alone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2018
- Study start23 Apr 2018
- Primary completion29 Aug 2023
- Study completion29 Aug 2023
Why it stopped: Insufficient recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Brain TumorsStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single group assignment
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jonathan E McConathy, University of Alabama at Birmingham
- Investigators
- Jonathan McConathy, MD, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03451123
- Sponsor's protocol ID
- R17-077
- Status last verified
- Dec 2023
- First submitted
- 23 Feb 2018
- Last updated
- 19 Dec 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
- ClinicalTrials.gov ID
- NCT03451123
- Acronym / sponsor ID
- R17-077
- Conditions
- Pediatric Brain Tumors
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 29 Aug 2023 (actual)
- Study completion
- 29 Aug 2023 (actual)
- First posted
- 1 Mar 2018 (actual)
- 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 primary objectives of this study are:
- Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone.
- Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.
A secondary objective of this study is:
- Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group assignment
| Arm | Type | Receives |
|---|---|---|
| FET-PET/MRI | Experimental | Drug: FET PET/MRIO-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.
- Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.
- Patient must be 18 years of age or younger at the time of study enrollment.
- Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
- Patient must have a life expectancy greater than 8 weeks.
Key exclusion criteria (6 listed)
- Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
- Patient must not have received radiation therapy within the past 6 months.
- Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
- Patient must not be pregnant or breast feeding.
- Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
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 |
|---|---|---|
| FET PET/MRIFET PET/MRI scan before and after surgery | Drug | FET-PET/MRI |
Primary outcome
Percentage of patients whose surgical plan change with FET-PET/MRI compared to MRI alone.
Time frame: 2 years
Surgical planning will be performed prior to brain tumor resection based on MRI alone and then with FET-PET/MRI. The surgical margins will be compared and the percentage of patients whose surgical plans change with FET-PET/MRI will be calculated.
Percentage of patients who have residual tumor after surgery detected with FET-PET/MRI
Time frame: 2 years
The percentage of patients with residual tumor identified with FET-PET/MRI will be measured. This percentage will be compared to detection of residual tumor by MRI alone.
Results and safety
The study was stopped early (reason given: Insufficient recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Jonathan McConathy, MD, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing FET PET/MRI in people with Pediatric Brain Tumors, run by University of Alabama at Birmingham 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 6 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 19 Dec 2023. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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: Insufficient recruitment). 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?
Percentage of patients whose surgical plan change with FET-PET/MRI compared to MRI alone. (time frame: 2 years). 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?
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 19 Dec 2023.