Axumin PET-CT for Brain Cancer

Recruiting in Palo Alto (17 mi)

Overseen by Yang Lu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: M.D. Anderson Cancer Center

Must be taking: Immunotherapy

Disqualifiers: Pregnancy, Severe allergies, Psychiatric illness, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

To learn if 18F-Fluciclovine (Axumin) PET-CT scans can be used to better detect brain metastatic lesions in patients who are receiving immunotherapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. It mentions that you must be on active immunotherapy, and other treatments are allowed as determined by your doctor.

What data supports the effectiveness of the drug Axumin PET-CT for brain cancer?

Research shows that [18F]Fluciclovine (Axumin) has been effective in diagnosing brain tumors, especially where other methods have limitations. It has also been used successfully in detecting prostate and breast cancers, indicating its potential usefulness in identifying various types of cancer.

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Is 18F-Fluciclovine (Axumin) safe for use in humans?

Research indicates that 18F-Fluciclovine (Axumin) has been evaluated for safety in various clinical trials, including those for brain tumors and prostate cancer. These studies generally support its safety as a PET/CT imaging agent in humans.

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How does Axumin PET-CT differ from other brain cancer treatments?

Axumin PET-CT uses a special tracer called 18F-fluciclovine to help visualize brain tumors more effectively than some other imaging methods, which can have limitations. This makes it unique in its ability to provide clearer images for diagnosing and assessing brain cancer.

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Eligibility Criteria

Adults over 18 with brain metastases from cancer, currently on immunotherapy, can join this trial. They must be able to consent, have a life expectancy of at least 3 months, and be willing to undergo additional scans or biopsies if needed. Pregnant or breastfeeding individuals, those with severe allergies to Axumin PET radiopharmaceuticals, or conditions affecting study compliance are excluded.

Inclusion Criteria

Willingness to participate in the study and ability to provide written informed consent.

You have been diagnosed with brain metastases, which are cancer that has spread to the brain.

Estimated life expectancy of at least 3 months as determined by the investigator or treating physician.

Exclusion Criteria

Patients with psychiatric illness/social situations that would limit compliance with study requirements.

Subjects with any medical condition or circumstance that the investigator believes may compromise the safety or compliance of the subject to produce reliable data or completing the study.

I have no severe allergies to Axumin PET scan dyes that can't be managed with medication.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1-2 visits (in-person)

Imaging

Participants undergo Axumin PET-CT scans to assess brain metastatic lesions

6-12 months

Up to 6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Participant Groups

The trial is testing whether a special type of PET-CT scan using a tracer called 18F-Fluciclovine (Axumin) is more effective in distinguishing between true progression and pseudo-progression of brain tumors in patients undergoing immunotherapy.

Group I: 18F-Fluciclovine (Axumin) Experimental Treatment 2 Interventions

Participants are expected to be in this research study for about 6-12 months. Participants will have up to 6 visits for screening tests, Axumin PET-CT scans, and information collection.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

M D Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center 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

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.

3. United States 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. [2017] (18)F-labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid ((18)F-fluciclovine) is a leucine analog PET/CT radiotracer that depicts amino acid transport into cells. Amino acid transport proteins have been shown to be upregulated in breast malignancies by microarray and immunohistochemical analysis, so we hypothesized that (18)F-fluciclovine may provide a novel method of visualizing breast cancer and now report a prospective clinical trial of (18)F-fluciclovine PET/CT in newly diagnosed advanced local invasive ductal carcinoma (IDC) and invasive lobular carcinoma (ILC).

4. 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.

5. Germany 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. [2021] [(18)F]Fluciclovine (anti-[(18)F]FACBC) is a synthetic amino acid developed for PET assessment of the anabolic component of tumour metabolism in clinical routine. This phase 1 trial evaluated the safety, tracer stability and uptake kinetics of [(18)F]fluciclovine in patients.

6. Japan 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. [2022] Label="OBJECTIVE" NlmCategory="OBJECTIVE">Glioma is the most common type of central nervous system tumor reported worldwide. Current imaging technologies have limitations in the diagnosis and assessment of glioma. The present study aimed to confirm the diagnostic efficacy and safety of anti-1-amino-3-[18F]fluorocyclobutane carboxylic acid (18F-fluciclovine; anti-[18F]FACBC) as a radiotracer for patients undergoing combined positron emission tomography and computed tomography (PET/CT) for suspected glioma.

7. 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.