GliomasPhase 2/3NCT01961934
C11-Sodium Acetate PET/CT Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
A Phase 2/3 study testing Sodium Acetate C11 PET/CT Imaging in people with Gliomas, run by Phoenix Molecular Imaging at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gliomas
- What is being tested?
- Sodium Acetate C11 PET/CT Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to May 2018
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Patients under the age of 18 years
- Claustrophobic patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
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.
Read the 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.
- Conditions
- Gliomas
- Being tested
- Sodium Acetate C11 PET/CT Imaging
- Keywords
- glioblastoma, high grade brain tumors, recurrent, pseudo-progression, radionecrosis, carbon acetate, C11 aceate, PET, positron emission tomography
- Medical subject headings
- Glioma, Glioblastoma, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Acetate C11 PET/CT ImagingDrug
Also called Carbon 11 Acetate, C11 Acetate, AC-PET, PET Imaging with Acetate C11
| Study group | Role | What they receive |
|---|---|---|
| Sodium Acetate C11 PET/CT Imaging | Experimental | Not described Receives: Drug: Sodium Acetate C11 PET/CT Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy Correlation
AC PET imaging results will be correlated with tissue biopsy results
Measured: 3 weeks from AC PET Imaging
Secondary outcomes (1)
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.
Measured: Day 1 - Assess at time of PET imaging
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startMay 2014
- Primary completionMay 2016 (estimated)
- Study completionMay 2018 (estimated)
Why it stopped: Awaiting funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phoenix Molecular Imaging
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Almeida MD, Phoenix Molecular Imaging
- Investigators
- Fabio Almeida, MD, Principal investigator, Medical Director, Phoenix Molecular Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01961934
- Sponsor's protocol ID
- AMIC-AC-003
- Status last verified
- Sep 2016
- First submitted
- 9 Oct 2013
- Last updated
- 28 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carbon-11-Sodium Acetate Positron Emission Tomography/Computed Tomography (PET/CT) Imaging Evaluation in Brain Glioma, Post Therapy Necrosis and Pseudo-progression
- ClinicalTrials.gov ID
- NCT01961934
- Acronym / sponsor ID
- AMIC-AC-003
- Conditions
- Gliomas
- Keywords
- glioblastoma, high grade brain tumors, recurrent, pseudo-progression, radionecrosis, carbon acetate, C11 aceate, PET
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Awaiting funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Phoenix Molecular ImagingUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sodium Acetate C11 PET/CT Imaging | Experimental | Drug: Sodium Acetate C11 PET/CT Imaging |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (2 listed)
- Patients under the age of 18 years
- Claustrophobic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium Acetate C11 PET/CT ImagingAlso: Carbon 11 Acetate, C11 Acetate, AC-PET, PET Imaging with Acetate C11 | Drug | Sodium Acetate C11 PET/CT Imaging |
Primary outcome
Biopsy Correlation
Time frame: 3 weeks from AC PET Imaging
AC PET imaging results will be correlated with tissue biopsy results
1 secondary outcome
SUV (Standardized Uptake Value)
Time frame: Day 1 - Assess at time of PET imaging
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2016.
Related trials for Gliomas
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Almeida, MD principal investigator
Medical Director, Phoenix Molecular Imaging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium Acetate C11 PET/CT Imaging in people with Gliomas, run by Phoenix Molecular Imaging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy Correlation (time frame: 3 weeks from AC PET Imaging). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2016.