F-Fluciclovine PET/MR Scan for Brain Cancer

Overseen By Radiology Studies

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Wisconsin, Madison

Disqualifiers: Pregnancy, Allergy to 18F-Fluciclovine, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

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

Compensation: Varies

Number of Visits: 1

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to use new imaging methods to help in finding out whether the imaging shows that there is a tumor in people with a brain metastasis. The main question it aims to answer is whether positron emission tomography (PET) and magnetic resonance imaging (MRI) find cancerous tissue better than other types of imagining. Participants will undergo a single PET/MRI scan, followed by a separate MRI scan with a tracer. Study participation will last about 3 hours.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it mentions that patients currently on or recently treated with systemic therapies are eligible, suggesting you may not need to stop them.

What data supports the effectiveness of the drug F-Fluciclovine (Axumin) for brain cancer?

Research shows that [18F]fluciclovine PET scans can detect brain tumor regions that might not be visible on regular MRI scans, suggesting it could be useful for identifying brain tumors. Additionally, a study found that [18F]fluciclovine is effective in diagnosing brain cancers where other methods fall short. ^{1 2 3 4 5}

Is F-Fluciclovine (Axumin) safe for use in humans?

F-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. ^{1 2 5 6 7}

How is the F-Fluciclovine PET/MR Scan treatment for brain cancer different from other treatments?

The F-Fluciclovine PET/MR Scan is unique because it uses a special radiotracer, 18F-fluciclovine, which is an artificial amino acid that helps detect brain tumors more effectively than some traditional imaging methods. This approach is particularly useful for identifying brain tumor regions that might not be visible on standard MRI scans. ^{1 2 3 7 8}

Research Team

Michael Veronesi, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

This trial is for adults over 18 with brain metastasis who are currently on immune checkpoint inhibitors. They must have had a visible lesion on a recent MRI and be able to lie still for imaging. Pregnant individuals, those unable to consent, or with allergies to the tracer or contraindications for PET/MRI cannot participate.

Inclusion Criteria

I have a brain tumor that can be seen on an MRI.

I am currently being treated with a drug that boosts my immune system to fight cancer.

I have had cancer treatments like surgery, radiation, or chemotherapy before.

Exclusion Criteria

I am allergic to 18F-Fluciclovine or its components.

Subject is pregnant

Subject unable or unwilling to provide informed consent

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo a single PET/MRI scan followed by a separate MRI scan with a tracer

3 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

1-2 weeks

Treatment Details

Interventions

• F-Fluciclovine

Trial Overview The study tests whether PET/MRI scans using an F-Fluciclovine radiotracer can better detect cancerous tissue in the brain compared to other imaging methods. Participants will undergo one combined PET/MRI scan and a separate MRI scan during about three hours of study participation.

Participant Groups

Group I: PET-MRI Experimental Treatment 1 Intervention

Participants will undergo F-Fluciclovine PET radiotracer and MRI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Blue Earth Diagnostics

Industry Sponsor

Trials

43

Recruited

3,100+

Findings from Research

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]

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]

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 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 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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

MRI and amino acid PET detection of whole-brain tumor burden. [2023]

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

Incidental Serous Cystadenoma Presenting as a Photopenic Pancreatic Defect on 18F-Fluciclovine PET/CT. [2023]

3. 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]

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]

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

18F-Fluciclovine PET for Assessment of Prostate Cancer with Histopathology as Reference Standard: A Systematic Review. [2021]

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

Metastatic Male Breast Cancer With Increased Uptake on 18F-Fluciclovine PET/CT Scan. [2018]

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]

8. Iran 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. [2020]