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18F-Fluciclovine PET/MRI for Brain Cancer
Study Summary
This trial is testing whether a new imaging agent can help find brain tumors that have come back or are still there after treatment.
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?
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- I am 18 years old or older.I am either male or female.I am currently pregnant, breastfeeding, or there's a chance I could be pregnant.I have been diagnosed with a brain tumor but haven't started treatment.I have liver or kidney problems.I had a confirmed brain tumor and received treatment, now being checked for changes or recurrence.I am allergic to 18F-Fluciclovine.
- Group 1: Axumin (fluciclovine-F18) PET/CT scan
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- 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
Has F-Fluciclovine (Axumin) been previously tested via PET/CT in other clinical trials?
"At the moment, 7 clinical trials are observing PET/CT with F-Fluciclovine (Axumin), of which one is in Phase 3. 28 different medical centres across the USA have studies running on this topic; a majority of them being located in Boston, Massachusetts."
Has the United States Food and Drug Administration (FDA) approved PET/CT with F-Fluciclovine (Axumin)?
"While there is a limited amount of information available on PET/CT with F-Fluciclovine's (Axumin) efficacy, the safety data for this phase 2 trial secured it a score of two."
Does this experiment represent an unprecedented undertaking?
"Since 2019, PET/CT with F-Fluciclovine (Axumin) has been subjected to multiple clinical trials. The inaugural study in this field was sponsored by Telix International Pty Ltd and had 140 participants. Following the success of Phase 1 testing, a second round of tests were approved for Phase 2 drug status. Currently, 7 active studies are underway across 21 cities worldwide."
Is there an open enrollment period for this research endeavor?
"Information retrieved from clinicaltrials.gov confirms that the medical trial, initially posted on August 24th 2020 and most recently modified on August 25th 2022, is currently enrolling participants."
What is the maximum number of participants being accepted into this research project?
"Affirmative, clinicaltrials.gov displays that this medical experiment is actively seeking participants. It was first advertised on August 24th 2020 and edited most recently on August 25th 2022. In total, 20 patients are needed from a single site."
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