Clinical trial NCT01961934: 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
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Gliomas
Keywords: glioblastoma
high grade brain tumors
recurrent
pseudo-progression
radionecrosis
carbon acetate
C11 aceate
PET
positron emission tomography
Lead sponsor: Phoenix Molecular Imaging
Sponsor class: OTHER
First posted: 2013-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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:

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.

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

Primary outcomes:
measure: Biopsy Correlation
timeFrame: 3 weeks from AC PET Imaging
Secondary outcomes:
measure: SUV (Standardized Uptake Value)
timeFrame: Day 1 - Assess at time of PET imaging
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Molecular Imaging
state: Arizona
Study officials:
affiliation: Medical Director, Phoenix Molecular Imaging
name: Fabio Almeida, MD
role: PRINCIPAL_INVESTIGATOR
References: