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New treatment option for Brain Metastases
Official title 18F-Fluciclovine PET Amino Acid Evaluation of Brain Metastasis Treated With Stereotactic Radiosurgery
ClinicalTrials.gov ID: NCT06048094
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.
Also referred to as Axumin, 18F-FACBC.
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
- This is a pilot imaging study in participants treated with stereotactic radiosurgery (SRS) to treat brain metastasis. The purpose of this study is to see whether 18F-Fluciclovine positron emission tomography (PET) can be used as a biomarker to measure response or progression of brain metastasis after SRS.
- 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
- Diagnosis of cancer with radiographic finding of brain metastasis
- Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
- Planned treatment with SRS as per the treating physician team
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to...
You likely can't join if
- Prior anaphylactic reaction to 18F-fluciclovine
- Radiographic evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Pregnant or positive serum pregnancy test within 14 days of registration
- Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of...
See the full eligibility criteria
- Diagnosis of cancer with radiographic finding of brain metastasis
- Any number of brain metastasis, with all lesions ≤ 2 cm in maximum dimension
- Planned treatment with SRS as per the treating physician team
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Individuals of reproductive potential need to employ two highly effective and acceptable forms of contraception for at least 4 weeks prior to screening and agree to use such a method during study participation up to an...
- Prior anaphylactic reaction to 18F-fluciclovine
- Radiographic evidence of leptomeningeal disease
- Prior whole-brain radiation therapy
- Inability to undergo MRI (e.g., due to safety reasons, such as presence of a pacemaker)
- Pregnant or positive serum pregnancy test within 14 days of registration
- Individuals expecting to be breastfeeding at the time of 18F-fluciclovine and unwilling to stop breast-feeding for 24 hours. Temporary cessation of breastfeeding for 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 and/or preclude informed consent\
- A legally authorized representative (LAR) may consent on a potential participant's behalf in the case of cognitive impairment, if in the investigator's opinion, that impairment would not prevent completion of the...
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.