F-18 Fluorodopa PET Scan for Brain Tumor

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Mayo Clinic

Must not be taking: Anti-dopaminergics, Dopamine agonists

Disqualifiers: Pregnancy, Nursing, Pacemaker, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging scan called a fluorine F 18 fluorodopa-labeled PET scan. The goal is to determine if this scan can help doctors better plan surgeries and radiation treatments for patients with newly discovered brain tumors, known as malignant gliomas. The trial involves a special PET scan and possibly an MRI before surgery. Individuals recently diagnosed with either high- or low-grade malignant gliomas who plan to undergo surgery or a biopsy might be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how this new imaging technique works in people, offering participants a chance to benefit from cutting-edge diagnostic advancements.

Will I have to stop taking my current medications?

If you are taking anti-dopaminergic or dopamine agonist medications, you may need to stop them at least 6 half-lives before the PET scan. For other medications, the protocol does not specify any requirements.

What prior data suggests that the fluorine F 18 fluorodopa-labeled PET scan is safe for planning surgery and radiation therapy?

A previous study found that patients generally tolerated Fluorodopa F-18 PET scans well. The most common side effect was discomfort at the injection site, such as pain, swelling, or redness. This imaging method is already approved for diagnosing other medical conditions, suggesting it is relatively safe. It helps doctors observe specific brain activities, making it useful for managing brain tumors. Although more research is needed, current evidence indicates it is safe for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using the F-18 Fluorodopa PET scan for brain tumors because it offers a new way to visualize brain activity with precision. Unlike conventional imaging techniques, this PET scan uses a special tracer, F-18 Fluorodopa, which highlights brain areas with abnormal activity, potentially allowing for better planning of surgical interventions. This approach aims to improve the accuracy of tumor resections and could enhance outcomes by ensuring more targeted radiation therapy. By potentially offering clearer images of tumors, this technique might lead to more personalized and effective treatment plans for patients with brain tumors.

What evidence suggests that the fluorine F 18 fluorodopa-labeled PET scan is effective for planning surgery and radiation therapy in treating malignant glioma?

Research has shown that the fluorine F 18 fluorodopa PET scan, which participants in this trial will undergo, effectively helps doctors better understand brain tumors. It identifies both aggressive and less aggressive tumors. This scan can determine if a tumor has returned or if changes result from previous treatments like radiation. It is more accurate than some other scans, especially for less aggressive tumors, making it a useful tool for planning surgery and radiation therapy for brain tumors. ^{5 6 7 8 9}

Who Is on the Research Team?

Nadia N. Laack, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a new diagnosis of high or low-grade malignant glioma, who are planning to have brain surgery (craniotomy and resection or biopsy). Participants must be able to provide medical records and consent. Women capable of becoming pregnant must test negative for pregnancy within 48 hours before receiving the study drug.

Inclusion Criteria

I am scheduled for brain surgery to remove or sample a tumor.

My kidney function is low but I can still join the study without contrast for the pMRI.

My MRI shows I might have a serious brain tumor.

Exclusion Criteria

I cannot have MRI scans with contrast due to a condition like having a pacemaker or kidney failure.

I cannot have an 18F-FDOPA PET scan due to Parkinson's or related medication.

I am not pregnant, nursing, or if capable of childbearing, I am willing to use contraception.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Pre-operative Imaging

Participants undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI

1 week

1 visit (in-person)

Surgery

Participants undergo stereotactic craniotomy

1 week

1 visit (in-person)

Radiation Therapy

Some participants may undergo radiation therapy

Varies

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

Annual visits

What Are the Treatments Tested in This Trial?

Interventions

• Fluorine F 18 Fluorodopa
• Radiation Therapy
• Radiation Therapy Treatment Planning/Simulation
• Therapeutic Conventional Surgery

Trial Overview

The trial studies how well a special PET scan using fluorine F 18 fluorodopa works in planning surgical and radiation treatments for brain tumors. It aims to improve treatment by providing better imaging techniques to guide doctors during these procedures.

How Is the Trial Designed?

Group I: Arm I Experimental Treatment 8 Interventions

Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 192 patients with localized prostate cancer, using prostate-based IGRT (P-IGRT) resulted in significantly lower acute gastrointestinal toxicities compared to bony structure-based IGRT (B-IGRT), with rates of 3% versus 11%.

Both P-IGRT and B-IGRT showed similar prostate-specific antigen failure-free survival rates at 3 years (95.5% for P-IGRT and 92.7% for B-IGRT), indicating that P-IGRT can reduce toxicity without compromising tumor control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Decreased acute toxicities of intensity-modulated radiation therapy for localized prostate cancer with prostate-based versus bone-based image guidance. Nakamura, K., Mizowaki, T., Inokuchi, H., et al.[2018]

Radiation oncologists are exploring various innovative approaches, such as interstitial implants and stereotactic radiosurgery, to enhance cure rates for primary brain tumors while aiming to reduce long-term side effects.

These new radiation techniques must be integrated into a comprehensive treatment plan that includes other therapies to effectively manage primary malignant brain tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving radiotherapy for brain tumors. Woo, SY., Maor, MH.[2005]

Intensity Modulated Radiation Therapy (IMRT) combined with Image Guided Radiation Therapy (IGRT) enhances treatment for head and neck cancer by improving tumor coverage while minimizing damage to normal tissues, leading to similar tumor control rates with less toxicity compared to conventional methods.

In the context of systemic therapy, platinum-based radiochemotherapy remains the standard treatment, and early evidence suggests that adding Cetuximab to cisplatin-based therapy does not provide additional benefits in primary treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current strategies in radiotherapy of head and neck cancer. Pütz, M., Wenz, F.[2021]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

Image-guided radiotherapy (IGRT) can lead to significant additional radiation exposure for patients, with kV-CBCT delivering a median dose of around 30 mGy to the pelvis, while 2D-kV imaging provides the lowest dose at less than 1 mGy per image pair.

Optimizing imaging protocols can substantially reduce radiation doses, potentially decreasing exposure by up to a factor of 10, highlighting the importance of tailored imaging strategies based on patient anatomy and treatment goals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. Le Deroff, C., Berger, L., Bellec, J., et al.[2022]

Radiation therapy is essential for treating brain tumors, utilizing various techniques to improve patient outcomes.

The review covers both traditional methods and advanced techniques like intensity-modulated radiotherapy and stereotactic radiosurgery, highlighting the evolution of treatment options available for effective tumor management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation techniques in neuro-oncology. Khuntia, D., Tomé, WA., Mehta, MP.[2021]

In a study involving 16 patients with recurrent low-grade astrocytoma and high-grade glioblastoma, (18)F-DOPA showed superior tumor-to-brain and tumor-to-blood ratios compared to (18)F-FET, indicating better imaging contrast for brain tumors outside the striatum.

While (18)F-DOPA provided better contrast ratios, (18)F-FET offered valuable insights into tumor grading and had lower uptake in the striatum, suggesting that both tracers have unique advantages depending on the imaging context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of ¹⁸F-FET and ¹⁸F-DOPA in PET imaging of recurrent brain tumors. Kratochwil, C., Combs, SE., Leotta, K., et al.[2022]

Radiotherapy is an important treatment option for both malignant and benign intracranial tumors, often used alongside neurosurgery to improve outcomes.

Stereotactic radiosurgery, particularly using gamma knife technology, is a highly precise method for irradiating tumors and is increasingly combined with systemic therapies to effectively treat metastatic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosurgical techniques for the treatment of brain neoplasms: A short review. Velnar, T., Bosnjak, R.[2020]

Citations

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sciencedirect.com

sciencedirect.com/science/article/pii/S0001299824000801

Update on the Role of [ 18 F]FDOPA PET/CT

Upon visual assessment, amino acid tracers such as [18F]FET, [11C]MET and [18F]FDOPA seem to perform equally well to identify primary brain tumors. The ...

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pmc.ncbi.nlm.nih.gov

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The purpose of our meta-analysis and systematic review was to evaluate and compare the diagnostic effectiveness of [18F]FET PET and [18F]FDOPA PET in detecting ...

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The Role of 18F-FDOPA PET Imaging

This imaging modality is particularly effective in differentiating a tumor recurrence from treatment-related changes such as radiation necrosis, ...

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18F-FDOPA PET imaging of brain tumors - PubMed - NIH

(18)F-FDOPA PET was more accurate than (18)F-FDG PET for imaging of low-grade tumors and evaluating recurrent tumors. (18)F-FDOPA PET may prove especially ...

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aacrjournals.org

aacrjournals.org/clincancerres/article/20/13/3550/78474/Treatment-Response-Evaluation-Using-18F-FDOPA-PET

Treatment Response Evaluation Using 18F-FDOPA PET in ...

It has been shown previously that 18F-FDOPA provides excellent visualization of high-grade as well as low-grade brain tumors (17–20). Furthermore, its uptake in ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/label/2019/200655s000lbl.pdf

FLUORODOPA F 18 Injection - accessdata.fda.gov

F 18 Injection is a radioactive diagnostic agent indicated for use in positron emission tomography (PET) to visualize dopaminergic nerve terminals in the ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06667726

An Investigational Scan (18F-DOPA PET/CT) for Improving ...

To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data ...

8.

synapse.patsnap.com

synapse.patsnap.com/article/what-are-the-side-effects-of-fluorodopa-f-18

What are the side effects of FLUORODOPA F-18?

One of the most commonly reported side effects of Fluorodopa F-18 is discomfort at the injection site. Patients might experience pain, swelling, or redness.

9.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7541204/

Usefulness of 18F-FDOPA PET for the management ...

It appears that 18 F-FDOPA PET holds promise as an effective additional tool in the management of gliomas. More consistent prospective studies are still needed.