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

The University of Alabama at Birmingham

Status and phase: Terminated; Early Phase 1

Conditions: Pediatric Brain Tumors

Treatments: Drug: FET PET/MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT03451123

R17-077

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

FET-PET/MRI

Experimental group

Description:

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

Treatment:

Drug: FET PET/MRI