C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression

Last updated: September 27, 2016
Sponsor: Phoenix Molecular Imaging
Overall Status: Trial Not Available

Phase

2/3

Condition

Brain Cancer

Brain Tumor

Neurofibromatosis

Treatment

N/A

Clinical Study ID

NCT01961934
AMIC-AC-003
  • Ages 18-70
  • All Genders

Study Summary

This study will investigate how well Carbon Acetate PET/CT imaging helps to correctly identify recurrent tumor versus post treatment effects (radionecrosis) in patients with previously treated high grade brain gliomas.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients age 18-70

  • Pathologically confirmed World Health Organization (WHO) grade 3 or 4 glioma

  • ECOG/Zubrod 0-2

  • Prior external beam radiotherapy to 59.4-60 Gray by 1.8-2 Gy fractions

  • Post-radiotherapy contrast-enhanced cranial MRI obtained at least 6 weeks after thecompletion of external beam radiotherapy shows enhancing anomaly (recurrent/progressive tumor versus pseudo-progression versus radionecrosis)

  • Patient completed at least a two week course of palliative steroid therapy for thisenhancing anomaly

  • No prior designated therapy other than steroids for presumed radionecrosis orrecurrent tumor

  • Patient with no clinical and/or radiological response to steroid therapy

  • Patient eligible for stereotactic brain biopsy

  • Patient eligible for focal laser therapy

Exclusion

Exclusion Criteria:

  • Patients under the age of 18 years

  • Claustrophobic patients

Study Design

Study Start date:
May 01, 2014
Estimated Completion Date:
May 31, 2018

Study Description

The study is designed to investigate the effectiveness of Carbon Acetate PET/CT (AC PET)in terms of its ability to distinguish between radionecrosis/pseudo-progression and viable tumor in patients previously treated with surgery and radiation for high grade glioma brain tumors.

Eligible patients with biopsy proven high grade gliomas (WHO grades 3 and 4) status-post prior cranial irradiation for this tumor; age 18 to 70; ECOG/Zubrod of 0-2, no other contraindications to trial entry, and a post-irradiation cranial MRI or CT demonstrating an enhancing lesion of uncertain etiology (not biopsied) will be treated with at least two weeks of steroidal therapy.

Responders to steroidal therapy will be classified as either pseudo-progression (if asymptomatic) or radionecrosis (if symptomatic). Non-responders (those who do not respond clinically, radiographically, or both) will be referred for an FDG PET/CT and initial AC PET/CT within 3 weeks, and subsequently referred for stereotactic biopsy of their lesion followed by focal laser treatment (in the same operative setting) within 3 weeks of AC PET/CT.

Specific Goals/Questions:

  1. What is the yield (sensitivity, accuracy, positive and negative predictive value) of state-of-the-art PET/CT with C-11 Acetate in detecting recurrent disease versus post treatment effects and pseudo-progression in this patient population?

  2. How does the performance of PET with C-11 Acetate compare with that of PET using F-18 fluorodeoxyglucose (FDG-PET) and with that of MRI?

  3. Evaluate the optimal timing for post injection imaging.

Connect with a study center

  • Phoenix Molecular Imaging

    Phoenix, Arizona 85040
    United States

    Site Not Available

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