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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of using imaging scans to detect brain tumors in individuals already diagnosed with brain metastasis (cancer that has spread to the brain). The goal is to determine if combining PET and MRI scans can identify cancerous tissue more effectively than traditional imaging methods. Participants will undergo two types of scans over approximately three hours, using a special tracer called F-Fluciclovine (also known as Axumin or 18F-Fluciclovine). The study seeks individuals with visible brain tumors on an MRI, who have received radiation therapy in the past two years, and whose doctors are uncertain whether their symptoms result from tumor growth or treatment effects. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants an opportunity to contribute to a promising advancement in cancer detection.

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 prior data suggests that this imaging method is safe for brain cancer patients?

Research has shown that F-Fluciclovine is generally safe. Studies have found that this PET tracer effectively detects tumors and is considered safe. Specifically, in adults with recurring brain tumors called gliomas, it proved both safe and effective, with no major safety issues reported.

Since this trial uses a tracer previously studied for similar brain conditions, it offers some confidence regarding its safety. Participants will only undergo imaging sessions, which are non-invasive. Therefore, F-Fluciclovine appears to be a safe option for detecting brain tumors in this study. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about F-Fluciclovine for brain cancer because it offers a new way to visualize tumors using PET/MR imaging. Unlike standard imaging techniques, which may not clearly differentiate tumor tissue from normal tissue, F-Fluciclovine is a radiotracer that targets amino acid transport, providing a clearer view of brain tumors. This enhanced visualization can potentially lead to more accurate diagnoses and better treatment planning, giving doctors a more precise tool in managing brain cancer.

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

In this trial, participants will undergo F-Fluciclovine PET/MRI scans. A previous study demonstrated that 18F-fluciclovine PET imaging accurately detects high-grade gliomas, aggressive brain tumors. Research has also found that this imaging method can distinguish between new tumor growth and dead tissue caused by radiation, which is crucial for accurate diagnosis. Another study showed that 18F-fluciclovine PET/MRI effectively identifies tumors that have recurred after treatment. These findings suggest that 18F-fluciclovine may better identify cancerous brain tissue compared to other imaging methods. ^{6 7 8 9 10}

Who Is on the Research Team?

Michael Veronesi, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05553041

18F-Fluciclovine PET-MRI in High-grade Glioma The purpose of this study is to see if 18F-fluciclovine (Axumin®) PET imaging is useful and safe in the management of children with High Grade Gliomas.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10742552/

Diagnostic Accuracy of PET with 18F-Fluciclovine ([18F ... Evidence-based data demonstrate the good diagnostic accuracy of [ 18 F]FACBC PET for HGG detection.

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. trials.braintumor.org trials.braintumor.org/trials/NCT04462419

18F-fluciclovine PET/MRI Imaging for the Detection of Tumor ... This phase I trial studies the ability and amount of fluciclovine positron emission tomography (PET) imaging needed to recognize tumors that have come back ( ...

5. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/18f-fluciclovine-pet-ct-helps-distinguish-radiation-necrosis-from-brain-tumor-progression

18F Fluciclovine PET CT Helps Distinguish Radiation ... 18F fluciclovine PET CT demonstrated promising utility in distinguishing radiation necrosis from tumor progression among patients treated with stereotactic ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5482923/

Diagnosis of Brain Tumors Using Amino Acid Transport PET ... Phase IIa clinical study of [18F]fluciclovine:efficacy and safety of a new PET tracer for brain tumors. Ann Nucl Med. 2016;30(9):608–18. doi: 10.1007/s12149 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT03276676

[18F]Fluciclovine and [18F]FLT PET/CT Assessment of ... The standard treatment approach for patients with high-grade primary brain tumors includes maximum feasible surgical resection, followed by 6 weeks of ...

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

Clinical Practice Guidelines for 18F-Fluciclovine 2024 in ... F-Fluciclovine is indicated for the "visualization of tumors in patients suspected of having newly diagnosed malignant gliomas, specifically to ...

10. jnm.snmjournals.org jnm.snmjournals.org/content/60/supplement_1/496

Safety and effectiveness of 18 F-fluciclovine PET in adults with ... Conclusions: 18F-Fluciclovine PET is well tolerated and able to effectively detect the presence of tumors in adults with recurrent gliomas.