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TerminatedNCT03451123Updated Dec 19, 2023

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

An Early Phase 1 interventional study of FET PET/MRI in Pediatric Brain Tumors, sponsored by University of Alabama at Birmingham. Terminated at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2023-12-19.

Sponsored by University of Alabama at Birmingham · Early Phase 1, Interventional, and Diagnostic

Why this study was terminated
Insufficient recruitment
Phase
Early Phase 1
Study type
Interventional
Enrollment
1
Allocation
Not applicable
Ages
6 Years to 18 Years
Sex
All
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Study summary

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.
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Conditions studied

  • Pediatric Brain Tumors

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03

Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Early Phase 1
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
1 participant (actual)

Study arms

  • Experimental
    FET-PET/MRI

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

    Drug: FET PET/MRI

Interventions

  • DrugFET PET/MRI

    FET PET/MRI scan before and after surgery

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

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Study locations

1 site
  • UAB Advanced Imaging Facility
    Birmingham, Alabama 35294, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03451123
Lead sponsor
University of Alabama at Birmingham
Responsible party
Jonathan E McConathy (Principal Investigator, University of Alabama at Birmingham) — Principal investigator
First posted
Mar 1, 2018
Start date
Apr 23, 2018
Primary completion
Aug 29, 2023
Completion
Aug 29, 2023
Last update
Dec 19, 2023

Study contacts

Jonathan McConathy, MD, PhD
principal investigator · University of Alabama at Birmingham

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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