Back to resultsFET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
Primary Purpose
Pediatric Brain Tumors
Status
Active
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
FET PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Pediatric Brain Tumors
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UAB Advanced Imaging Facility
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FET-PET/MRI
Arm Description
O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03451123
First Posted
February 23, 2018
Last Updated
June 29, 2023
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT03451123
Brief Title
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
Official Title
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 23, 2018 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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:
1) Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Brain Tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Single group assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FET-PET/MRI
Arm Type
Experimental
Arm Description
O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI
Intervention Type
Drug
Intervention Name(s)
FET PET/MRI
Intervention Description
FET PET/MRI scan before and after surgery
Primary Outcome Measure Information:
Title
Percentage of patients whose surgical plan change with FET-PET/MRI compared to MRI alone.
Description
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.
Time Frame
2 years
Title
Percentage of patients who have residual tumor after surgery detected with FET-PET/MRI
Description
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.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan McConathy, MD, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Advanced Imaging Facility
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
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