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New treatment option for Brain Metastases, Adult
Official title Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
ClinicalTrials.gov ID: NCT04689048
What this study is testing
What is 18F fluciclovine?
18F fluciclovine is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for brain metastases, adult.
Also referred to as Axumin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female, age ≥18 years
- Performance status, Eastern Cooperative Oncology Group 0-2
- Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
- Plan for SSRS per the treating team
- For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
You likely can't join if
- Prior anaphylactic reaction to 18F-fluciclovine
- Evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Females pregnant at the expected time of 18F-fluciclovine administration
- Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation...
See the full eligibility criteria
- Male or female, age ≥18 years
- Performance status, Eastern Cooperative Oncology Group 0-2
- Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
- Plan for SSRS per the treating team
- For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
- For females of reproductive potential: use of highly effective contraception for at least 4 weeks prior to screening and agreement to use such a method during study participation and for an additional 1 week after...
- Prior anaphylactic reaction to 18F-fluciclovine
- Evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Females pregnant at the expected time of 18F-fluciclovine administration
- Females who are expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding 24 hours after the time of imaging is allowed
- Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
The study team makes the final eligibility decision.
Where it's taking place
- Miami, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Miami, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.