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

NCT03451123 | Terminated Early Phase 1 FDA Drug

• 1 other identifier: R17-077
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objectives of this study are:

1. 1.Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone.
2. 2.Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.

Conditions

Pediatric Brain Tumors

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

FET-PET/MRI

EXPERIMENTAL

O-(2-\[F-18\]FET)-L-tyrosine (FET) for brain PET/MRI

Drug: FET PET/MRI

Interventions

FET PET/MRI DRUG

FET PET/MRI scan before and after surgery

FET-PET/MRI

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Advanced Imaging Facility

Birmingham, Alabama, 35294, United States

Location

Study Officials

• Jonathan McConathy, MD, PhD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single group assignment

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: April 23, 2018
• Primary Completion: August 29, 2023
• Study Completion: August 29, 2023
• Last Updated: December 19, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)