A Phase 2 interventional study of 18F-FET in Glioblastoma Multiforme and GBM, sponsored by Marcelo F. Di Carli, MD, FACC. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-10-30.
Sponsored by Marcelo F. Di Carli, MD, FACC · Phase 2, Interventional, and Diagnostic
Hypothesis: The central hypothesis underlying the proposed research study is that FET-PET will predict durable benefit in patients receiving anti-angiogenic benefit for presumed recurrent GBM (i.e. progression-free survival and overall survival). We have defined one primary specific aim, for which we expect to obtain definitive results, and two secondary aims, under which we plan to generate preliminary data to support a future, larger project.
The PET radiotracer FET provides a measure of large, neutral amino acid transport. This transport is significantly upregulated in malignant brain tumors. FET rarely gives false positive findings in the setting of inflammation seen after high dose chemotherapy or radiotherapy. FET labels low-grade as well as high-grade gliomas, in contrast to FDG, which almost exclusively labels only high-grade gliomas. FET imaging may prove to be particularly useful in the setting of infiltrative tumor, which is not contrast-enhancing on MRI and therefore not detectable with FDG. Management of glioblastoma patients with stable contrast-enhancing disease on MRI but increased signs of edema is difficult. This is because it is difficult to distinguish simple edema from infiltrative tumor. The former is managed with steroids and the latter is managed with chemotherapy, and anti-angiogenic drugs.
FET may be particularly useful in assessing changes after GBM patients receive anti-vascular agents such as Avastin. Avastin is very commonly used in patients after failure of first-line treatment in GBM. Not only is Avastin costly, but it also can have serious side effects such as internal bleeding and gastric perforation, severe hypertension, poor wound healing, and renal toxicity. It is important to know when a patient is failing Avastin treatment so that the drug can be discontinued. Preliminary data in Europe (see figures below) suggests that FET-PET can accurately distinguish Avastin responders from non-responders.
Inclusion Criteria:
Exclusion Criteria:
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's enrollment of 13 is below the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Marcelo F. Di Carli, MD, FACC is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patient lives too far from BWH and/or is unwilling/ unable to return for scheduled imaging visits.
-
Recurrent GBM patients receiving Avastin, imaged twice with 18F-FET PET before and approximately 8 weeks after receiving Avastin
Drug: 18F-FET
Radiotracer, surrogate marker for protein synthesis
Also known as: 18F-Fluoroethyltyrosine
Progression-free Survival
The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.
Time frame: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.
Overall Survival
The secondary objective is to assess the utility of FET-PET imaging for prediction of overall survival in recurrent glioblastoma.
Time frame: From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.
| Milestone | GBM Avastin Receiving 18F-FET |
|---|---|
| Started | 13 |
| Completed | 12 |
| Not completed | 1 |
| Withdrew: Moved away and lost to followup | 1 |
The primary objective is to assess the utility of FET-PET imaging for prediction of progression-free survival in recurrent glioblastoma.
| days | GBM Avastin Receiving 18F-FET |
|---|---|
| Progression-free Survival | 158.25 ± 161.7 |
The secondary objective is to assess the utility of FET-PET imaging for prediction of overall survival in recurrent glioblastoma.
| days | GBM Avastin Receiving 18F-FET |
|---|---|
| Overall Survival | 270.58 ± 222.00 |
Collected over From date of baseline PET scan until the date of death from any cause, assessed up to 2 years.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| GBM Avastin Receiving 18F-FET | 12/12 (100%) | 0/12 (0%) | 2/12 (16.7%) |
| Event | GBM Avastin Receiving 18F-FET |
|---|---|
| BruisingVascular disorders | 2/12 |
| Age, Categorical(Participants) | GBM Avastin Receiving 18F-FET |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 9 |
| >=65 years | 3 |
| Age, Continuous(years) | GBM Avastin Receiving 18F-FET |
|---|---|
| Mean | 61.4 (18 to 74) |
| Sex: Female, Male(Participants) | GBM Avastin Receiving 18F-FET |
|---|---|
| Female | 4 |
| Male | 8 |
| Region of Enrollment(participants) | GBM Avastin Receiving 18F-FET |
|---|---|
| United States | 12 |
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Marcelo F. Di Carli, MD, FACC