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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment. PURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma

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 data supports the effectiveness of this treatment for brain tumors?

Research shows that advanced radiotherapy techniques, like stereotactic radiotherapy and radiosurgery, are effective in treating brain tumors by precisely targeting tumor cells while sparing healthy tissue. These methods have improved outcomes when combined with surgery, enhancing the overall treatment effectiveness for brain tumors. ^{1 2 3 4 5}

Is the F-18 Fluorodopa PET Scan for Brain Tumor generally safe for humans?

Image-guided radiation therapy (IGRT) and intensity-modulated radiation therapy (IMRT) are generally considered safe, with improvements in technology reducing side effects and preserving normal tissue. Studies show reduced toxicity and better safety profiles compared to older methods, making them safer options for treating various conditions. ^{6 7 8 9 10}

What makes the F-18 Fluorodopa PET Scan treatment for brain tumors unique?

The F-18 Fluorodopa PET Scan treatment is unique because it combines high-resolution imaging with metabolic information to improve the precision of targeting brain tumors during radiation therapy and surgery. This approach helps differentiate between tumor recurrence and radiation injury, enhancing treatment planning and monitoring. ^{11 12 13 14 15}

Research Team

Nadia N. Laack, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Improving radiotherapy for brain tumors. [2005]

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

Stereotactic radiotherapy for pediatric and adult brain tumors: preliminary report. [2019]

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

Radiation techniques in neuro-oncology. [2021]

4. Germany pubmed.ncbi.nlm.nih.gov

[Radiotherapy of primary brain tumors]. [2016]

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

Radiosurgical techniques for the treatment of brain neoplasms: A short review. [2020]

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

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Neural stem cell sparing by linac based intensity modulated stereotactic radiotherapy in intracranial tumors. [2021]

8. Japan 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. [2018]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Monte Carlo-based software for 3D personalized dose calculations in image-guided radiotherapy. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Current strategies in radiotherapy of head and neck cancer. [2021]

11. England pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of ¹⁸F-FET and ¹⁸F-DOPA in PET imaging of recurrent brain tumors. [2022]

12. Hungary pubmed.ncbi.nlm.nih.gov

[F-DOPA PET/MR based target definiton in the 3D based radiotherapy treatment of glioblastoma multiforme patients. First Hungarian experiences]. [2022]

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

Brain tumors. [2021]

14. Greece pubmed.ncbi.nlm.nih.gov

Current status of 18F-DOPA PET imaging in the detection of brain tumor recurrence. [2016]

15. England pubmed.ncbi.nlm.nih.gov

¹⁸F-fluorodopa positron-emission tomography: an emerging imaging modality for patients with brain metastases. [2016]