Assess Use of 18F-Fluciclovine for Patients With Large Brain Metastases Treated With Staged Stereotactic Radiosurgery
Recruiting
Phase 1Interventional Study
Brain Metastases, AdultBrain MetastasesBrain Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Prevention
Participants needed
20 (estimated)
Sponsor
Baptist Health South Florida · Other
Who this trial is looking for
This trial is looking for adults with brain metastases who have at least one untreated lesion. Participants will help researchers see how well a new imaging agent works to track changes in their condition after radiation therapy.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have been diagnosed with brain metastases
I have at least one untreated brain metastasis larger than 2 cm
I will be receiving staged stereotactic radiosurgery
If I am a woman who can become pregnant, I have a negative pregnancy test
If I am a woman of reproductive potential, I am using effective contraception
You may not be able to join if
I have had a severe allergic reaction to 18F-fluciclovine
I have evidence of leptomeningeal disease
I have had whole-brain radiation therapy before
I cannot have an MRI for safety reasons
I am pregnant or plan to be pregnant at the time of imaging
I will be breastfeeding at the time of imaging and cannot stop for 24 hours
I have a major medical illness or mental impairment that prevents completion of the study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over…
The spread of cancer to the brain is referred to as brain metastases. Brain metastases are a common complication of cancer. This study is being done to determine whether the use of a new imaging agent, 18F-fluciclovine, is able to detect which patients are responding to radiation therapy. In addition, this study will look at the changes of the treated brain metastases using this imaging agent over time.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Male or female, age ≥18 years
2. Performance status, Eastern Cooperative Oncology Group 0-2
3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
4. Plan for SSRS per the treating team
5. For women of childbearing potential, …
Inclusion Criteria:
1. Male or female, age ≥18 years
2. Performance status, Eastern Cooperative Oncology Group 0-2
3. Confirmed diagnosis of brain metastases with at least one untreated lesion \>2 cm in maximum diameter
4. Plan for SSRS per the treating team
5. For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required
6. 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 post-treatment 18F-fluciclovine positron emission tomography/computerized tomography
Exclusion Criteria:
1. Prior anaphylactic reaction to 18F-fluciclovine
2. Evidence of leptomeningeal disease
3. Prior whole-brain radiation therapy
4. Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)
5. Females pregnant at the expected time of 18F-fluciclovine administration
6. 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
7. Major medical illness or psychiatric/cognitive impairments, which in the investigator's opinion, will prevent completion of protocol therapy and/or preclude informed consent
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