18F-Fluciclovine Imaging for Brain Metastases

Recruiting at 1 trial location

Overseen By Rupesh R Kotecha, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Baptist Health South Florida

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new imaging agent, 18F-fluciclovine, can identify how well patients with brain metastases respond to radiation therapy. The study uses this agent to take detailed brain scans before, during, and after treatment to track changes. It suits individuals diagnosed with brain metastases who have at least one untreated tumor larger than 2 cm. As a Phase 1 trial, this research focuses on understanding the treatment's effects in people, offering participants the opportunity to be among the first to receive this new imaging agent.

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 prior data suggests that this imaging agent is safe for detecting brain metastases?

Research shows that 18F-fluciclovine, also known as Axumin, is generally safe and well-tolerated. Studies have used it to help doctors see brain cancer more clearly with special imaging tests like PET/CT scans, which are similar to X-rays but provide more detailed pictures.

Unwanted effects are rare with 18F-fluciclovine. It is administered through a small needle in the vein, which might cause mild discomfort, but serious side effects are uncommon. Research suggests that any side effects are usually mild and temporary, such as slight pain at the injection site.

For those considering joining a trial with 18F-fluciclovine, it is reassuring that previous studies have not shown major safety concerns. However, discussing any worries with the study team is essential to receive the most accurate and personalized information. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about 18F-fluciclovine imaging for brain metastases because it offers a new way to visualize cancer spread in the brain. Unlike standard imaging techniques, this method uses the radiotracer 18F-fluciclovine, which is specifically designed to highlight cancerous tissue more clearly during PET/CT scans. This could potentially lead to more accurate and earlier detection of brain metastases, allowing for better-targeted treatments and improved patient outcomes. The ability to conduct pre-, interim-, and post-treatment scans with this imaging agent also provides a dynamic view of how the disease progresses and responds to therapy, which is something that current options might not offer as effectively.

What evidence suggests that 18F-fluciclovine imaging is effective for detecting brain metastases?

Research has shown that 18F-fluciclovine, which participants in this trial will receive, effectively detects cancer activity. In one study, this imaging agent accurately distinguished between returning cancer and radiation damage in the brain. This capability helps determine if tumors respond to treatment. Another study confirmed its accuracy in identifying areas where cancer has returned after brain cancer treatments. Overall, 18F-fluciclovine appears to be a reliable tool for monitoring brain tumor response to therapy. ^{2 3 6 7}

Who Is on the Research Team?

Rupesh R Kotecha, MD

Principal Investigator

Miami Cancer Institute (MCI) at Baptist Health, Inc.

Are You a Good Fit for This Trial?

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 can take care of myself and perform daily activities.

For women of childbearing potential, a negative serum pregnancy test within 14 days of registration is required

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• 18F fluciclovine

Trial Overview 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.

How Is the Trial Designed?

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.

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Published Research Related to This Trial

The PET tracer 18F-fluciclovine (Axumin) has been approved for use in men suspected of having recurrent prostate cancer after previous treatment, indicating its potential role in improving diagnosis.

Studies utilizing systematic sector-based histopathology as a reference standard have been conducted to evaluate the diagnostic accuracy of 18F-fluciclovine PET, highlighting its importance in clinical settings for prostate cancer management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. Seierstad, T., Hole, KH., Tulipan, AJ., et al.[2021]

18F-fluciclovine PET/CT is effective for detecting biochemically recurrent prostate cancer, but it can also reveal incidental findings, such as a pancreatic head mass.

In this case, the pancreatic mass appeared as a photopenic defect on the PET/CT scan and was later confirmed to be a benign serous cystadenoma through MRI, highlighting the importance of further investigation for unexpected findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidental Serous Cystadenoma Presenting as a Photopenic Pancreatic Defect on 18F-Fluciclovine PET/CT. Waltz, J., Mercer, MK., Dani, G., et al.[2023]

The 18 F-fluciclovine PET/CT scan effectively identified intense uptake in left adrenal gland metastasis in a prostate cancer patient, highlighting its utility in detecting visceral metastasis.

In contrast, the 18 F-NaF PET/CT scan showed intense uptake in multiple sclerotic bone metastases, indicating that both imaging techniques are necessary for a comprehensive evaluation of metastatic prostate cancer, as they provide complementary information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complementary Role of 18 F-Fluciclovine PET/CT and 18 F-NaF PET/CT in Detecting Prostate Cancer Metastasis. Xu, F., Liu, F., Chen, W.[2023]

The FDA recently approved F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC, F-fluciclovine) PET/CT scans for detecting suspected prostate cancer recurrence in men with elevated PSA levels after treatment.

In a unique case study of a 77-year-old man, the scan revealed not only suspected recurrent prostate cancer but also advanced-stage breast cancer, highlighting the potential for incidental findings during prostate imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. Gill, HS., Tade, F., Greenwald, DT., et al.[2018]

In a study involving 41 patients, the integration of (18)F-fluciclovine PET-CT into radiation therapy planning for prostate cancer significantly altered treatment target volumes in 83% of detected abnormalities, indicating its utility in improving treatment accuracy.

The use of (18)F-fluciclovine allowed for more precise targeting of cancerous areas, with 51% of changes occurring in lymph nodes, suggesting that this radiotracer can enhance the effectiveness of post-surgery radiation therapy.

NCBI (Pubmed)

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. Schreibmann, E., Schuster, DM., Rossi, PJ., et al.[2018]

In a phase IIa study involving 5 patients with malignant glioma, anti-[18F]FACBC demonstrated the ability to identify tumor regions that were not visible on conventional CE-T1W MRI, suggesting it may provide a more comprehensive assessment of glioma spread.

The safety profile of anti-[18F]FACBC was favorable, with only mild adverse events reported, indicating that it is a safe diagnostic tool for patients undergoing treatment for malignant glioma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase IIa clinical study of [18F]fluciclovine: efficacy and safety of a new PET tracer for brain tumors. Kondo, A., Ishii, H., Aoki, S., et al.[2017]

In a study involving 13 rats with implanted glioblastoma cells, [18F]fluciclovine PET showed similar sensitivity for detecting tumor burden compared to conventional MRI, with median sensitivities of 0.67 for PET and 0.61 for MRI.

Combining [18F]fluciclovine PET with MRI significantly improved detection sensitivity to 0.86, which was 41% higher than MRI alone, indicating that using both imaging techniques together may enhance the assessment of brain tumor burden.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. Chen, P., Scarpelli, ML., Healey, DR., et al.[2023]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2024-09643

18F-Fluciclovine (Axumin) PET/CT for Detecting True This clinical trial tests the effectiveness of fluciclovine F18 (Axumin) positron emission tomography (PET)-computed tomography (CT) in detecting cancer ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7721921/

Fluciclovine PET discrimination of recurrent intracranial ... Using a SUVmax threshold of ≥ 1.3, fluciclovine PET demonstrated a 100% accuracy in distinguishing recurrent disease from radiation necrosis up to 30 min after ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.2001

Evaluating the diagnostic performance of 18 F-fluciclovine ... This is the first prospective multicenter trial to evaluate PET characteristics of suspected recurrent BM after RT, verified by histopathology.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05554302

Characterization of 18F-Fluciclovine PET Amino Acid ... This study is for patients who have had surgery to remove brain metastasis and are planned to have stereotactic radiosurgery (SRS) after their brain surgery ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06015295

NCT06015295 | A Pilot Study to Assess the ... To assess the diagnosis accuracy of 18F-Fluciclovine (Axumin) PET-CT in detecting true- versus pseudo-progression of brain metastatic lesions in patients on ...

6. trials.braintumor.org trials.braintumor.org/trials/NCT06055790

Feasibility of 18F-Fluciclovine PET/CT to Identify Brain ... The goal of this diagnostic intervention clinical trial is to compare 18F-Fluciclovine uptake within brain lesions over 60 minutes compared with standard of ...

7. link.springer.com link.springer.com/article/10.1007/s12149-025-02089-6

Clinical Practice Guidelines for 18F-Fluciclovine 2024 in ... This guideline provides a comprehensive overview of the clinical characteristics of 18F-Fluciclovine in malignant glioma, including indications ...