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Osimertinib + PET Imaging for Recurrent Glioblastoma
Study Summary
This trial is testing how well a new cancer drug works with a new medical imaging technology to treat patients with a certain type of brain tumor.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- My liver enzyme levels are higher than normal due to my cancer.I have had surgery for permanent sterilization, not including tubal ligation.It's been over 4 weeks or 5 half-lives since I last took any experimental drugs.My kidney function is reduced, with high creatinine and low clearance.I cannot take pills due to severe nausea, vomiting, gut diseases, or major bowel surgery.It has been 3 weeks since my last non-nitrosourea chemotherapy.My tumor shows EGFR activation based on specific tests.My bilirubin levels are higher than normal, but it's due to my condition.I am allergic to osimertinib or similar drugs.I agree to use contraception during and for 4 months after the study.It has been at least 12 weeks since I finished my radiation treatment.It has been 6 weeks since my last nitrosourea chemotherapy.I have had lung conditions that needed steroid treatment.My tumor does not have a p53 mutation.I can care for myself but may need occasional help.My MRI shows a tumor that is at least 1cm big.It has been over 4 weeks since my last bevacizumab treatment.It's been over 4 weeks since I last took any FDA-approved medication.I am not pregnant and will use birth control during the study.I have been treated with drugs targeting EGFR before.I have not been in this study or treated with osimertinib before.I have a heart condition.I am a woman under 50, have not had periods for 12 months or more, and my hormone levels confirm I am postmenopausal.I can take pills by mouth.I am not pregnant, not breastfeeding, and use effective birth control or cannot become pregnant.I have recovered from the major side effects of my previous treatments.I am taking or can't stop taking certain medications or supplements that affect my liver enzymes.I am over 50 and have not had a period for at least 12 months since stopping hormone treatments.I do not have severe illnesses or infections like uncontrolled high blood pressure, active bleeding disorders, hepatitis B, hepatitis C, or HIV.I have a high-grade brain tumor that has grown or come back after treatment.I don't have severe side effects from past treatments, except for hair loss or mild nerve issues.My liver enzyme levels are higher than normal due to my cancer.My cancer's EGFR/p53 status is known from past tests.I have conditions or take medications that could affect my heart's rhythm.I have agreed to participate in genetic research.It's been 2 weeks since I last took a non-chemotherapy cancer drug.
- Group 1: Treatment (18F-FDG PET, osimertinib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is Fludeoxyglucose F-18 an innocuous treatment method?
"The safety profile of Fludeoxyglucose F-18 is appraised to be a 2 due to the fact that this trial is in its second stage, with evidence suggesting it may have some protective properties but no reported efficacy."
Is this research offering participants at the present time?
"Clinicaltrials.gov indicates that recruitment for this particular trial has closed, as the last update occurred on March 2nd 2022. Nonetheless, there are 1535 other trials which remain open and actively seeking participants."
How many participants are enrolled in this investigation?
"At this moment in time, patient recruitment for this medical trial has been suspended. It was originally posted to clinicaltrials.gov on November 28th 2018 and most recently updated on March 2nd 2022. Thankfully, there are numerous other studies recruiting; 1417 trials searching for glioblastoma patients and 118 seeking out participants with Fludeoxyglucose F-18 complications remain open."
Is this experiment a novel one or has it been done before?
"Research into Fludeoxyglucose F-18 began in 2013, with an initial trial backed by AstraZeneca and involving 603 participants. Subsequently, the drug was approved for Phase 1 & 2 trials and today is under investigation at 118 locations across 1063 cities within 51 nations."
What is the aim of this experimental endeavor?
"This clinical trial's primary objective will be to evaluate the change in Fluorodeoxyglucose (FDG) uptake after short-term exposure to osimertinib. Secondary outcomes include concentrations of osimertinib and its metabolites AZ5104 and AZ7550 within post-dosing plasma samples, which will be summarised with appropriate statistical measures. Moreover, a Kaplan–Meier curve will present descriptive data on Progression Free Survival (PFS), while a Receiver Operating Characteristic (ROC) analysis using leave one out cross validation techniques will investigate the correlation between reduced glucose uptake and 6 months PFS."
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