No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
46 (estimated)
Sponsor
Baptist Health South Florida · Other
Who this trial is looking for
This trial is looking for patients who have cancer that has spread to the brain and are treated with a specific method called stereotactic radiosurgery. Participants will take part in imaging tests to see how their condition responds after treatment.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with cancer that has spread to my brain.
I have brain metastases that are 2 cm or smaller.
I will be treated with stereotactic radiosurgery.
My performance status is 0-2 as per ECOG criteria.
I will use effective contraception if I could become pregnant.
You may not be able to join if
I have had an allergic reaction to 18F-fluciclovine.
I have evidence of leptomeningeal disease.
I have had whole-brain radiation therapy before.
I cannot undergo an MRI for safety reasons.
I am pregnant or tested positive for pregnancy recently.
I am breastfeeding and cannot stop for 24 hours.
I have a major medical illness or cognitive impairment that prevents me from participating.
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 three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion 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
*…
Inclusion 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 additional 1 week following the last 18F-fluciclovine PET
Exclusion Criteria:
* 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 protocol.
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