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

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.

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.

Study Overview

• Status: Terminated
• Conditions: Pediatric Brain Tumors
• Intervention / Treatment: Drug: FET PET/MRI

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • UAB Advanced Imaging Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. 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.
3. Patient must be 18 years of age or younger at the time of study enrollment.
4. Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
5. Patient must have a life expectancy greater than 8 weeks.
6. Patient must be able to undergo FET-PET/MRI without sedation.
7. 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:

1. Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
2. Patient must not have received radiation therapy within the past 6 months.
3. Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
4. Patient must not be pregnant or breast feeding.
5. Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
6. Patients must not have a history of brain metastases.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Investigators: Principal Investigator: Jonathan McConathy, MD, PhD, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2018
• Primary Completion (Actual): August 29, 2023
• Study Completion (Actual): August 29, 2023

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: February 23, 2018
• First Posted (Actual): March 1, 2018

Study Record Updates

• Last Update Posted (Estimated): December 19, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: R17-077

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No