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

Primary Purpose

Gliomas

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sodium Acetate C11 PET/CT Imaging
Sponsored by
Phoenix Molecular Imaging
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gliomas focused on measuring glioblastoma, high grade brain tumors, recurrent, pseudo-progression, radionecrosis, carbon acetate, C11 aceate, PET, positron emission tomography

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Phoenix Molecular Imaging

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium Acetate C11 PET/CT Imaging

Arm Description

Outcomes

Primary Outcome Measures

Biopsy Correlation
AC PET imaging results will be correlated with tissue biopsy results

Secondary Outcome Measures

SUV (Standardized Uptake Value)
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.

Full Information

First Posted
October 9, 2013
Last Updated
September 27, 2016
Sponsor
Phoenix Molecular Imaging
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1. Study Identification

Unique Protocol Identification Number
NCT01961934
Brief Title
C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
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 Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Awaiting funding
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
May 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Phoenix Molecular Imaging

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: 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? 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? Evaluate the optimal timing for post injection imaging.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gliomas
Keywords
glioblastoma, high grade brain tumors, recurrent, pseudo-progression, radionecrosis, carbon acetate, C11 aceate, PET, positron emission tomography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sodium Acetate C11 PET/CT Imaging
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Sodium Acetate C11 PET/CT Imaging
Other Intervention Name(s)
Carbon 11 Acetate, C11 Acetate, AC-PET, PET Imaging with Acetate C11
Primary Outcome Measure Information:
Title
Biopsy Correlation
Description
AC PET imaging results will be correlated with tissue biopsy results
Time Frame
3 weeks from AC PET Imaging
Secondary Outcome Measure Information:
Title
SUV (Standardized Uptake Value)
Description
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.
Time Frame
Day 1 - Assess at time of PET imaging

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio Almeida, MD
Organizational Affiliation
Medical Director, Phoenix Molecular Imaging
Official's Role
Principal Investigator
Facility Information:
Facility Name
Phoenix Molecular Imaging
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85040
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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