FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors

Study Overview
=================
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.

Official Title
-----------------
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors

Conditions
-----------------
Pediatric Brain Tumors

Intervention / Treatment
-----------------
* Drug: FET PET/MRI


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Single group assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FET-PET/MRI<br>O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI | Drug: FET PET/MRI<br>* FET PET/MRI scan before and after surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 2 years |