18F-Fluciclovine Imaging for Brain Metastases

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Rupesh R Kotecha, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Baptist Health South Florida

Disqualifiers: Leptomeningeal disease, Prior whole-brain radiation, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What data supports the effectiveness of the drug 18F-fluciclovine for brain metastases?

Research shows that 18F-fluciclovine has been effective in detecting brain tumors where other imaging methods fall short, suggesting it could be useful for identifying brain metastases.

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Is 18F-Fluciclovine safe for use in humans?

18F-Fluciclovine (Axumin) has been widely used and approved for detecting prostate cancer recurrence, indicating it is generally considered safe for human use in this context.

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How does the drug 18F-Fluciclovine differ from other treatments for brain metastases?

18F-Fluciclovine is unique because it is a PET/CT radiotracer that can detect brain tumor regions that might not be visible on standard MRI scans, potentially offering a more comprehensive assessment of brain tumor burden.

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Eligibility Criteria

Adults over 18 with brain metastases and at least one untreated lesion larger than 2 cm can join this trial. They must have a performance status of 0-2, not be pregnant or breastfeeding (or willing to stop for the study), and agree to use effective contraception. Those with MRI contraindications, prior whole-brain radiation, or severe medical/psychiatric issues cannot participate.

Inclusion Criteria

I am using, and will continue to use, effective birth control during and after the study.

I am 18 years old or older.

I can take care of myself and perform daily activities.

Exclusion Criteria

Contraindication to MRI (e.g., due to safety reasons, such as presence of a pacemaker)

Prior anaphylactic reaction to 18F-fluciclovine

My cancer has spread to the lining of my brain and spinal cord.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-treatment Imaging

Participants undergo pre-treatment 18F-fluciclovine PET/CT and MRI scans to assess brain metastases

1 week

1 visit (in-person)

Radiation Treatment

Participants receive staged stereotactic radiosurgery (SSRS) for brain metastases

6-8 weeks

Interim Imaging

Participants undergo interim 18F-fluciclovine PET/CT scans to monitor response to radiation therapy

1 week

1 visit (in-person)

Post-treatment Imaging

Participants undergo post-treatment 18F-fluciclovine PET/CT and MRI scans to evaluate changes in brain metastases

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Participant Groups

The trial is testing if a new imaging agent called 18F-fluciclovine can show how well patients with large brain metastases respond to staged stereotactic radiosurgery (SSRS). It will also monitor changes in the treated lesions using this agent over time.

Group I: PET/CT, MRI Experimental Treatment 1 Intervention

In total, three 18F-fluciclovine PET/CT brain scans (pre-, interim-, and post-treatment) will be performed according to the study calendar. Generic name is Axumin and will be administered as an intravenous bolus. May administer diluted or undiluted. The maximum volume of undiluted 18F-fluciclovine is 5 mL. After administration, flush with normal saline to ensure full delivery of the dose.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Miami Cancer Institute at Baptist Health, Inc Miami, FL

Miami Cancer Institute Miami, FL

Who Is Running the Clinical Trial?

Baptist Health South Florida Lead Sponsor

Blue Earth Diagnostics Industry Sponsor

References

1. Japan pubmed.ncbi.nlm.nih.gov

Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. [2017] Label="OBJECTIVE" NlmCategory="OBJECTIVE">[18F]Fluciclovine (anti-[18F]FACBC) has demonstrated diagnostic efficacy for cancers of the brain where [18F]fludeoxyglucose has limitations. We conducted a phase IIa study of anti-[18F]FACBC to assess its accumulation pattern and safety in patients with malignant glioma.

2. United States pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. [2021] The PET tracer 18F-fluciclovine (Axumin) was recently approved in the United States and Europe for men with suspected prostate cancer recurrence following prior treatment. This article summarizes studies where systematic sector-based histopathology was used as reference standard to assess the diagnostic accuracy of the tracer 18F-fluciclovine PET in patients with prostate cancer.

3. United States pubmed.ncbi.nlm.nih.gov

Incidental Serous Cystadenoma Presenting as a Photopenic Pancreatic Defect on 18F-Fluciclovine PET/CT. [2023] 18F-fluciclovine (Axumin) PET/CT has been widely used for the evaluation of biochemically recurrent prostate cancer following prior treatment. While lymph node and visceral organ metastases typically show increased radiotracer uptake, altered patterns of normal physiologic activity may also provide insight into other disease processes. We present a case of an incidental pancreatic head mass presenting as a photopenic defect on a staging 18F-fluciclovine PET/CT, which was subsequently confirmed to be a benign serous cystadenoma using multisequence MRI.

4. United States pubmed.ncbi.nlm.nih.gov

Complementary Role of 18 F-Fluciclovine PET/CT and 18 F-NaF PET/CT in Detecting Prostate Cancer Metastasis. [2023] We present different findings on 18 F-fluciclovine (Axumin) PET/CT and 18 F-NaF PET/CT images in a patient with prostate cancer metastasis. 18 F-Fluciclovine PET/CT scan showed intense uptake in left adrenal gland metastasis, only faint to mild uptake in multiple sclerotic osseous metastasis where 18 F-NaF bone PET/CT demonstrated intense uptake at these sites. Both examinations are needed to accurately evaluate visceral and osseous metastasis from prostate cancer.

5. Switzerland pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. [2023] Label="Background" NlmCategory="UNASSIGNED">[18F]fluciclovine amino acid PET has shown promise for detecting brain tumor regions undetected on conventional anatomic MRI scans. However, it remains unclear which of these modalities provides a better assessment of the whole brain tumor burden. This study quantifies the performance of [18F]fluciclovine PET and MRI for detecting the whole brain tumor burden.

6. United States pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. [2018] Prostate imaging with F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC, F-fluciclovine) PET/CT scan (Axumin) was recently approved by the US Food and Drug Administration for men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen levels following prior treatment. We present a rare case of a 77-year-old man with suspected recurrent prostate cancer with an incidental finding of advanced-stage breast cancer showing different degrees of F-fluciclovine uptake.

7. United States pubmed.ncbi.nlm.nih.gov

Image Guided Planning for Prostate Carcinomas With Incorporation of Anti-3-[18F]FACBC (Fluciclovine) Positron Emission Tomography: Workflow and Initial Findings From a Randomized Trial. [2018] (18)F-Fluciclovine (anti-1-amino-3-[(18)F]fluorocyclobutane-1-carboxylic acid) is a novel positron emission tomography (PET)/computed tomography (CT) radiotracer that has demonstrated utility for detection of prostate cancer. Our goal is to report the initial results from a randomized controlled trial of the integration of (18)F-fluciclovine PET-CT into treatment planning for defining prostate bed and lymph node target volumes.