Brain CancerNCT02849171
Assessing 11C-Choline (11C-CH) PET to Distinguish True Tumor Progression From Pseudoprogression in High-grade Gliomas
A study testing PET scan and C-Choline in people with Brain Cancer, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This is a pilot study. The purpose of this study is to test if an imaging tracer, not approved by the FDA, called 11C-Choline (11C-CH) is useful for evaluating your type of cancer. This tracer is used to perform PET scans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Cancer
- What is being tested?
- PET scan and C-Choline
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to 6 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Patient is able to provide written informed consent prior to study registration
- Histologically-confirmed high-grade glioma
- Completion of treatment with standard radiation (with or without concurrent therapy).
- Standard gadolinium-enhanced MRI changes that are considered indeterminate for tumor progression vs. treatment-related changes by the neuroradiologist or clinician within 24 weeks of completion of radiation.
Who cannot join
- Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
- Renal insufficiency with recent (<3 month old) creatinine > 2.0 mg/dL
- Pregnant or nursing female
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Pilot Study of 11C-Choline (11C-CH) PET in Assessing Post-treatment True Tumor Progression From Pseudo-progression in High-grade Gliomas
This is a pilot study. The purpose of this study is to test if an imaging tracer, not approved by the FDA, called 11C-Choline (11C-CH) is useful for evaluating your type of cancer. This tracer is used to perform PET scans. The researchers want to see if the 11C-CH PET scan, using the study tracer 11C-CH, can improve upon the usual scans at diagnosing or monitoring your type of cancer.
In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It is important to distinguish true tumor growth from inflammation since inflammation indicates the tumor is responding to treatment. With standard MRI, it is difficult to determine if changes following treatment are due to tumor growth or inflammation early on. Researchers hope to learn if the investigational tracer, 11C-CH, will be able to distinguish true tumor growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.
- Conditions
- Brain Cancer
- Being tested
- PET scan, C-Choline
- Keywords
- 11C-Choline (11C-CH) PET, 16-676, High-grade Gliomas
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanDevice
C-CholineRadiation
| Study group | Role | What they receive |
|---|---|---|
| high-grade glioma | Experimental | Eligible patients must have undergone standard radiation (typically 60Gy in 30 fractions), with or without concurrent drug therapy, and have MRI findings consistent with tumor progression and/or pseudoprogression within 24 weeks after completion of radiation. Eligible patients will undergo an 11C-CH PET study within 2 weeks of the standard of care MRI that shows changes concerning for tumor progression vs. pseudoprogression. All patients will then be followed with surveillance brain MRI with and without contrast as per standard of care for a period of 11 months, to assess further progression or stabilization of the lesion. Initial MRI changes are considered to represent pseudoprogression/treatment related changes if the lesion stabilizes or becomes smaller without a change in tumor-related therapy. Otherwise, it will be considered a recurrence should there be progessive radiographic changes. Receives: Device: PET scan; Radiation: C-Choline |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUV Measures
from 11C-CH PET with evolving changes on brain MRI in high-grade glioma after radiotherapy. In a small subgroup of patients required surgery, tissue will be analyzed for histopathologic correlate. The data gathered will not be considered definitive, but rather will be used to as preliminary data in support of a larger, definitive study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2016 (estimated)
- Study startJul 2016
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Brain CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ronald Blasberg, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02849171
- Sponsor's protocol ID
- 16-676
- Status last verified
- May 2022
- First submitted
- 12 Jul 2016
- Last updated
- 29 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of 11C-Choline (11C-CH) PET in Assessing Post-treatment True Tumor Progression From Pseudo-progression in High-grade Gliomas
- ClinicalTrials.gov ID
- NCT02849171
- Acronym / sponsor ID
- 16-676
- Conditions
- Brain Cancer
- Keywords
- 11C-Choline (11C-CH) PET, 16-676, High-grade Gliomas
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 29 Jul 2016 (estimated)
- Results
- Posted 29 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a pilot study. The purpose of this study is to test if an imaging tracer, not approved by the FDA, called 11C-Choline (11C-CH) is useful for evaluating your type of cancer. This tracer is used to perform PET scans. The researchers want to see if the 11C-CH PET scan, using the study tracer 11C-CH, can improve upon the usual scans at diagnosing or monitoring your type of cancer.
In patients with high-grade gliomas, changes on standard MRI of the brain may reflect true tumor growth or inflammatory changes in response to treatment, called pseudo-progression. It is important to distinguish true tumor growth from inflammation since inflammation indicates the tumor is responding to treatment. With standard MRI, it is difficult to determine if changes following treatment are due to tumor growth or inflammation early on. Researchers hope to learn if the investigational tracer, 11C-CH, will be able to distinguish true tumor growth from inflammation more accurately than standard MRI or 18F-FDG PET scans.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| high-grade glioma | Experimental | Device: PET scan, Radiation: C-CholineEligible patients must have undergone standard radiation (typically 60Gy in 30 fractions), with or without concurrent drug therapy, and have MRI findings consistent with tumor progression and/or pseudoprogression within 24 weeks after completion of radiation. Eligible patients will undergo an 11C-CH PET study within 2 weeks of the standard of care MRI that shows changes concerning for tumor progression vs. pseudoprogression. All patients will then be followed with surveillance brain MRI with and without contrast as per standard of care for a period of 11 months, to assess further progression or stabilization of the lesion. Initial MRI changes are considered to represent pseudoprogression/treatment related changes if the lesion stabilizes or becomes smaller without a change in tumor-related therapy. Otherwise, it will be considered a recurrence should there be progessive radiographic changes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Patient is able to provide written informed consent prior to study registration
- Histologically-confirmed high-grade glioma
- Completion of treatment with standard radiation (with or without concurrent therapy).
- Standard gadolinium-enhanced MRI changes that are considered indeterminate for tumor progression vs. treatment-related changes by the neuroradiologist or clinician within 24 weeks of completion of radiation.
Key exclusion criteria (3 listed)
- Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
- Renal insufficiency with recent (<3 month old) creatinine > 2.0 mg/dL
- Pregnant or nursing female
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 |
|---|---|---|
| PET scan | Device | high-grade glioma |
| C-Choline | Radiation | high-grade glioma |
Primary outcome
SUV Measures
Time frame: 1 year
from 11C-CH PET with evolving changes on brain MRI in high-grade glioma after radiotherapy. In a small subgroup of patients required surgery, tissue will be analyzed for histopathologic correlate. The data gathered will not be considered definitive, but rather will be used to as preliminary data in support of a larger, definitive study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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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.
Ronald Blasberg, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET scan and C-Choline in people with Brain Cancer, run by Memorial Sloan Kettering Cancer Center 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 29 Dec 2022. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SUV Measures (time frame: 1 year). 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 29 Dec 2022.