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

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ClinicalTrials.gov Identifier: NCT01961934
Recruitment Status : Withdrawn (Awaiting funding)
First Posted : October 14, 2013
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
Fabio Almeida MD, Phoenix Molecular Imaging

Brief 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.

Condition or disease Intervention/treatment Phase
Gliomas Drug: Sodium Acetate C11 PET/CT Imaging Phase 2 Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
Study Start Date : May 2014
Estimated Primary Completion Date : May 2016
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium Acetate C11 PET/CT Imaging Drug: Sodium Acetate C11 PET/CT Imaging
Other Names:
  • Carbon 11 Acetate
  • C11 Acetate
  • AC-PET
  • PET Imaging with Acetate C11




Primary Outcome Measures :
  1. Biopsy Correlation [ Time Frame: 3 weeks from AC PET Imaging ]
    AC PET imaging results will be correlated with tissue biopsy results


Secondary Outcome Measures :
  1. SUV (Standardized Uptake Value) [ Time Frame: Day 1 - Assess at time of PET imaging ]
    Imaging studies will be evaluated both qualitatively and quantitatively using SUV (standardized uptake values): a measure of metabolism based on injected dose, patient weight and region of interest. Comparison of the lesional activity to normal contralateral tracer activity will also be measured.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 the completion 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 this enhancing anomaly
  • No prior designated therapy other than steroids for presumed radionecrosis or recurrent 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 Criteria:

  • Patients under the age of 18 years
  • Claustrophobic patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01961934


Locations
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United States, Arizona
Phoenix Molecular Imaging
Phoenix, Arizona, United States, 85040
Sponsors and Collaborators
Phoenix Molecular Imaging
Investigators
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Principal Investigator: Fabio Almeida, MD Medical Director, Phoenix Molecular Imaging

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Responsible Party: Fabio Almeida MD, Medical Director/PI, Phoenix Molecular Imaging
ClinicalTrials.gov Identifier: NCT01961934     History of Changes
Other Study ID Numbers: AMIC-AC-003
First Posted: October 14, 2013    Key Record Dates
Last Update Posted: September 28, 2016
Last Verified: September 2016
Keywords provided by Fabio Almeida MD, Phoenix Molecular Imaging:
glioblastoma
high grade brain tumors
recurrent
pseudo-progression
radionecrosis
carbon acetate
C11 aceate
PET
positron emission tomography
Additional relevant MeSH terms:
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Glioma
Disease Progression
Necrosis
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Disease Attributes
Pathologic Processes