18F-DOPA PET/CT Scans for Brain Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Mayo Clinic

Disqualifiers: Pregnancy, Nursing, others

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 1 day

47 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Fluorodopa F 18 for brain cancer?

Research shows that Fluorodopa F 18 is effective in visualizing brain tumors, especially low-grade gliomas, with high sensitivity and accuracy. It is also useful in detecting brain tumor recurrence after treatment, offering advantages over other imaging methods. ^{1 2 3 4 5}

Is 18F-DOPA PET/CT safe for humans?

18F-DOPA, used in PET/CT scans for brain and other tumors, is generally considered safe for humans as it is a commonly employed radiotracer in medical imaging, although specific safety data is not detailed in the provided studies. ^{2 6 7 8 9}

How does the 18F-DOPA PET/CT scan treatment for brain cancer differ from other treatments?

The 18F-DOPA PET/CT scan is unique because it uses a special tracer, 18F-DOPA, which is an amino acid analog that helps visualize brain tumors with high sensitivity and accuracy. This method is particularly effective for detecting low-grade gliomas and monitoring tumor recurrence, offering a clear distinction between tumor and normal brain tissue due to its specific uptake patterns. ^{2 3 4 8 10}

Research Team

Derek R. Johnson, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility Criteria

This trial is for adults with a brain tumor who need advanced imaging, like before surgery or to check if treatment is working. It's not for those unable to undergo PET scans or pregnant/nursing individuals.

Inclusion Criteria

Ability to give appropriate consent or have an appropriate representative available to do so

I have been diagnosed with a brain tumor.

I need a special PET scan for surgery planning or to check if my treatment is working.

Exclusion Criteria

Patient is unable to undergo PET imaging

Persons who are pregnant or nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive 18F-DOPA intravenously and undergo PET/CT over 30 minutes on day 1

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 days

1 visit (virtual)

Extended Follow-up

Participants are monitored for adverse events and clinical impact up to 64 days post-treatment

64 days

Treatment Details

Interventions

• Fluorodopa F 18

Trial Overview The study tests whether adding an investigational scan called 18F-DOPA PET/CT can improve the management of brain tumors when combined with standard imaging techniques over half the time.

Participant Groups

Group I: Diagnostic (18F-DOPA) Experimental Treatment 3 Interventions

Patients receive 18F-DOPA IV and undergo PET/CT over 30 minutes on day 1.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

A study involving 37 patients with various grades of brain tumors demonstrated that a 3-compartment model effectively describes the kinetics of (18)F-FDOPA, revealing significant differences in uptake between high-grade and low-grade tumors.

High-grade tumors exhibited higher transport rates and distinct uptake curves compared to low-grade tumors, indicating that (18)F-FDOPA can be a useful tool for differentiating tumor grades in neurooncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-FDOPA kinetics in brain tumors. Schiepers, C., Chen, W., Cloughesy, T., et al.[2016]

In a study of 59 patients with newly diagnosed or recurrent gliomas, (18)F-FDOPA PET imaging showed significantly higher uptake in high-grade tumors compared to low-grade tumors, indicating its potential as a noninvasive marker for tumor grading.

The study found a strong correlation between (18)F-FDOPA uptake and tumor proliferation in newly diagnosed gliomas, suggesting that this imaging technique could help assess tumor activity and aggressiveness, although this correlation was not present in recurrent tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation of 6-18F-fluoro-L-dopa PET uptake with proliferation and tumor grade in newly diagnosed and recurrent gliomas. Fueger, BJ., Czernin, J., Cloughesy, T., et al.[2016]

The radiotracer (18)F-FDOPA is effective in diagnosing and monitoring Parkinson's disease by targeting presynaptic dopaminergic terminals in the brain, which helps in assessing disease progression and may influence drug development.

In addition to its use in Parkinson's disease, (18)F-FDOPA shows high sensitivity and accuracy in visualizing brain tumors, particularly low-grade gliomas and neuroendocrine tumors, due to its role as a precursor for neurotransmitters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

3,4-dihydroxy-6-[18f]-fluoro-L-phenylalanine positron emission tomography in patients with central motor disorders and in evaluation of brain and other tumors. Seibyl, JP., Chen, W., Silverman, DH.[2016]

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]

The new 18F-labeled l-DOPA analogue, [18F]FPDOPA, was successfully synthesized with a good yield and specific activity, making it a promising candidate for PET imaging of tumors.

In vivo studies showed that [18F]FPDOPA accumulates significantly in various tumor types, indicating its potential as a more effective PET tracer for brain tumors compared to the commonly used [18F]FDG.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiosynthesis and biological evaluation of N-(2-[18F]fluoropropionyl)-3,4-dihydroxy-l-phenylalanine as a PET tracer for oncologic imaging. Tang, C., Nie, D., Tang, G., et al.[2018]

The study compared the production of the radiotracer 6-[18F]F-L-DOPA at three clinical sites, revealing that the electrophilic synthesis method has a lower production failure rate despite being more complex, making it reliable for clinical use.

Among the nucleophilic methods, the five-step approach yielded better radiochemical results but required more sophisticated equipment, while the three-step method had lower yields but produced higher molar activity, which is crucial for certain clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

GMP production of 6-[18F]Fluoro-L-DOPA for PET/CT imaging by different synthetic routes: a three center experience. Andersen, VL., Soerensen, MA., Dam, JH., et al.[2021]

The study found that L-type amino acid transporters (LAT1 and LAT2) are significantly overexpressed in pheochromocytoma (PHEO) and medullary thyroid carcinoma (MTC) compared to normal tissues, with LAT1 showing a particularly strong increase in PHEO (15.1-fold).

This overexpression of LAT1 provides a molecular basis for the increased uptake of 18F-FDOPA in these tumors, which can enhance the effectiveness of PET imaging in clinical management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overexpression of L-Type Amino Acid Transporter 1 (LAT1) and 2 (LAT2): Novel Markers of Neuroendocrine Tumors. Barollo, S., Bertazza, L., Watutantrige-Fernando, S., et al.[2019]

References

1. Greece pubmed.ncbi.nlm.nih.gov

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

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

18F-FDOPA kinetics in brain tumors. [2016]

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

Correlation of 6-18F-fluoro-L-dopa PET uptake with proliferation and tumor grade in newly diagnosed and recurrent gliomas. [2016]

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

3,4-dihydroxy-6-[18f]-fluoro-L-phenylalanine positron emission tomography in patients with central motor disorders and in evaluation of brain and other tumors. [2016]

5. England pubmed.ncbi.nlm.nih.gov

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

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

Radiosynthesis and biological evaluation of N-(2-[18F]fluoropropionyl)-3,4-dihydroxy-l-phenylalanine as a PET tracer for oncologic imaging. [2018]

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

GMP production of 6-[18F]Fluoro-L-DOPA for PET/CT imaging by different synthetic routes: a three center experience. [2021]

8. Spain pubmed.ncbi.nlm.nih.gov

[Dual time point 18F-FDOPA PET as a tool for characterizing brain tumors]. [2019]

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

Overexpression of L-Type Amino Acid Transporter 1 (LAT1) and 2 (LAT2): Novel Markers of Neuroendocrine Tumors. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Molecular imaging of brain tumors with 18F-DOPA PET and PET/CT. [2016]