18F-Fluciclovine PET/CT for Brain Cancer

Overseen By Sarah A Fermawi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Arizona

Disqualifiers: Recent brain biopsy, Prior brain surgery, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction 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 tests a special scan called 18F-Fluciclovine PET/CT to evaluate its effectiveness for individuals with brain cancer that has metastasized. The goal is to determine if this scan can better indicate whether brain lesions are growing, healing, or merely causing side effects from previous treatments. Participants will undergo a scan before and after their standard brain cancer treatments to compare results. This trial suits those with brain lesions confirmed by a recent MRI and who are scheduled for brain cancer treatment. As a Phase 2 trial, this research measures the scan's effectiveness in an initial, smaller group, allowing participants to contribute to advancements in brain cancer imaging.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor to get a clear answer.

What prior data suggests that 18F-Fluciclovine PET/CT is safe for brain cancer diagnosis?

Studies have shown that 18F-Fluciclovine PET/CT is generally well-tolerated for brain cancer imaging. Research indicates that this method can help detect brain tumors, especially when other techniques like MRI (Magnetic Resonance Imaging) are less effective.

Regarding safety, 18F-Fluciclovine has already received approval for imaging prostate cancer, indicating a well-understood safety profile. No major reports of side effects have specifically emerged from its use in brain imaging studies. The trial's Phase 2 status suggests that earlier studies demonstrated sufficient safety to warrant testing in more participants.

Overall, 18F-Fluciclovine PET/CT seems to be a safe option for those considering clinical trials for brain cancer imaging. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which typically involve surgery, radiation, and chemotherapy, 18F-Fluciclovine PET/CT provides a unique diagnostic approach. This technique uses a special radioactive tracer to highlight cancerous cells on a PET/CT scan, offering clearer images of brain metastases. Researchers are excited about this method because it can potentially detect cancer spread earlier and more accurately than traditional imaging techniques, helping doctors tailor treatments more effectively.

What evidence suggests that this diagnostic method is effective for brain cancer?

Research has shown that 18F-Fluciclovine PET/CT scans, which participants in this trial will undergo, can help detect cancer in the brain. One study found that it might identify tumor tissue that regular MRI scans miss. Another study showed that this method could effectively identify cancer that has returned to the brain. This means it might help determine if cancer is recurring or if changes seen on an MRI are merely effects of treatment. Overall, 18F-Fluciclovine PET/CT has shown promise in improving the accuracy of brain cancer diagnosis. ^{1 2 3 6 7}

Who Is on the Research Team?

Bital Savir-Baruch, MD

Principal Investigator

University of Arizona

Are You a Good Fit for This Trial?

This trial is for adults over 18 with suspected or confirmed brain metastases from known cancer, who've had a positive MRI within the last two months and are scheduled for brain lesion treatment. They must be able to lie still for a PET/CT scan and sign consent. Excluded are those treated after their last MRI, with recent biopsies, prior brain surgery or radiation on the lesion, or unable to tolerate the exam.

Inclusion Criteria

I have a history of cancer.

I can lie still on my back for a PET/CT scan.

I have or might have cancer spread to my brain.

Exclusion Criteria

Concurrent or prior enrollment on other clinical trials would not exclude patients, as long as all other eligibility criteria are met

You cannot undergo the 18F-fluciclovine PET/CT exam.

I have had brain surgery or radiation for my current brain tumor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline PET/CT Scan

Participants undergo an initial 18F-fluciclovine PET/CT scan to characterize uptake dynamics within brain lesions over 60 minutes

1 day

1 visit (in-person)

Post-Treatment PET/CT Scan

Participants undergo a second 18F-fluciclovine PET/CT scan to evaluate uptake in treated lesions over 60 minutes, concurrent with post-procedure SOC MRI

2 months from baseline

1 visit (in-person)

Follow-up PET/CT Scan

A third 18F-fluciclovine PET/CT scan is offered to evaluate post-radiation changes and differentiate necrosis from recurrence for patients under clinical surveillance

Up to 3 years from baseline

1 visit (in-person) for up to 10 patients

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• 18F-Fluciclovine PET/CT

Trial Overview The trial tests how well an imaging agent called 18F-Fluciclovine shows up in brain lesions using PET/CT scans. It compares uptake dynamics before and after treatment like surgery or radiation therapy against standard MRI results to distinguish true progression of disease from tissue damage due to treatment.

How Is the Trial Designed?

Group I: 18F-Fluciclovine (Axumin) PET/CT Experimental Treatment 1 Intervention

Patients with recently diagnosed brain metastatic lesion(s) will be recruited based on MRI with or without histological confirmation, per standard of care. All patients will undergo an 18F-fluciclovine head PET/CT scan prior to treatment for brain metastatic lesions, post treatment, and 3 years post treatment.

Who Is Running the Clinical Trial?

University of Arizona

Lead Sponsor

Trials

545

Recruited

161,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Published Research Related to This Trial

FACBC-PET imaging demonstrated higher contrast in detecting gliomas compared to L-methyl-11C-methionine (MET)-PET, suggesting it may be more effective for glioma diagnosis.

In a study involving six patients suspected of having gliomas, FACBC showed higher lesion-to-normal brain tissue ratios than MET, indicating better assessment capabilities for glioma detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis of Brain Tumors Using Amino Acid Transport PET Imaging with 18F-fluciclovine: A Comparative Study with L-methyl-11C-methionine PET Imaging. Tsuyuguchi, N., Terakawa, Y., Uda, T., et al.[2020]

18F-fluciclovine (18F-FACBC) shows a 100% detection rate in gliomas and glioblastomas, indicating its potential as a highly effective diagnostic tool for these brain tumors.

FACBC PET imaging outperforms traditional MRI in accurately defining tumor extent and volumes, and it offers similar accuracy to methionine with improved tumor-to-background contrast, suggesting it could be a valuable addition to glioma diagnostics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Fluciclovine (18F-FACBC) PET/CT or PET/MRI in gliomas/glioblastomas. Albano, D., Tomasini, D., Bonù, M., et al.[2020]

In a study involving 45 patients with suspected glioma, 18F-fluciclovine PET/CT demonstrated a high positive predictive value of 88.0% for identifying tumor areas that were not visible on traditional imaging, aiding in surgical planning.

The use of 18F-fluciclovine PET/CT led to modifications in the planned extent of tumor resection in nearly half of the cases, indicating its potential to improve surgical outcomes for glioma patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determining the extent of tumor resection at surgical planning with 18F-fluciclovine PET/CT in patients with suspected glioma: multicenter phase III trials. Wakabayashi, T., Hirose, Y., Miyake, K., et al.[2022]

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]

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]

The phase 1 trial involving six patients with prostate cancer demonstrated that [(18)F]fluciclovine is safe for human use, with no significant adverse events reported and minimal urine excretion of the tracer.

[(18)F]fluciclovine effectively visualized tumor deposits in prostate cancer, showing high uptake within the first 15 minutes post-injection, which suggests that early imaging provides the best results for assessing tumor metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regional distribution and kinetics of [18F]fluciclovine (anti-[18F]FACBC), a tracer of amino acid transport, in subjects with primary prostate cancer. Sörensen, J., Owenius, R., Lax, M., et al.[2021]

The study involved 27 women with newly diagnosed locally advanced invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC), and found that (18)F-fluciclovine PET/CT effectively visualized all cases of breast cancer, including detecting previously unsuspected extraaxillary nodal metastases in some patients.

While (18)F-fluciclovine showed strong concordance in measuring metabolic tumor volume compared to (18)F-FDG, the weak concordance for SUVmax indicates that these two imaging agents may reflect different biological processes in tumors, suggesting that (18)F-fluciclovine could provide unique insights into breast cancer biology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Results of a Prospective Clinical Trial of 18F-Fluciclovine PET/CT in Newly Diagnosed Invasive Ductal and Invasive Lobular Breast Cancers. Ulaner, GA., Goldman, DA., Gönen, M., et al.[2017]

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/PMC9653108/

Diagnostic Value of 18F-FACBC PET/MRI in Brain ... 18 F-FACBC PET/MRI did not improve detection of brain metastases compared with MRI but might detect tumor tissue beyond contrast enhancement on MRI.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04410133

NCT04410133 | Study to Establish the Diagnostic ... To assess lesion-level PPV & NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases. MRI for anatomical correlation within 3 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06015295

NCT06015295 | A Pilot Study to Assess the ... To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy. Detailed ...

5. 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.

6. trials.braintumor.org trials.braintumor.org/trials/NCT06048094

18F-Fluciclovine PET Amino Acid Evaluation of Brain ... 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 ...

7. withpower.com withpower.com/trial/phase-2-neoplasm-metastasis-9-2022-a3d7b

18F-Fluciclovine Imaging for Brain Tumors The available research shows that 18F-Fluciclovine is effective in detecting brain tumors, especially in cases where other imaging methods like MRI have ...