N/A
Completed N=8
Assessing 11C-Choline (11C-CH) PET to Distinguish True Tumor Progression From Pseudoprogression in High-grade Gliomas
Source: ClinicalTrials.gov NCT02849171 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Dec 2022
Primary outcomePrimary: SUV Measures
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. 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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SUV Measures |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Inability to undergo or cooperate with an MRI or PET scan (e.g., claustrophobia, metal implant)
- Renal insufficiency with recent ( 2.0 mg/dL
- Pregnant or nursing female
Data sourced from ClinicalTrials.gov (NCT02849171). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.