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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether adding a special scan called 18F-DOPA PET/CT to regular imaging methods can help doctors better manage brain tumors in more than half of the cases. The 18F-DOPA PET/CT scan uses a tiny amount of a radioactive substance (Fluorodopa F 18) to provide detailed images of the brain, enhancing tumor detection. This approach may improve treatment planning and monitoring for those with brain tumors. Suitable candidates for this trial include individuals with a brain tumor diagnosis who require detailed imaging for surgery planning or other treatment decisions. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to advancements in brain tumor management.

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 prior data suggests that the 18F-DOPA PET/CT scan is safe for brain cancer patients?

Research has shown that Fluorodopa F 18 is generally safe for people. Previous studies have used this substance in various imaging tests, including those for brain tumors and other conditions. The most common side effect is mild discomfort at the injection site, such as pain, swelling, or redness.

Fluorodopa F 18 is used in small amounts for imaging, which helps minimize radiation exposure for patients and healthcare workers. Its use in imaging for other medical conditions suggests it is reasonably safe. Prospective participants should consult a healthcare professional about any concerns before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using 18F-DOPA PET/CT scans for brain cancer because this approach offers a new way to visualize tumor activity. Unlike traditional MRI or CT scans, which provide images of the brain's structure, 18F-DOPA PET/CT scans use the radioactive tracer Fluorodopa F 18 to show how active the cancer cells are. This method can help doctors see the difference between healthy brain tissue and cancerous tissue more clearly and potentially catch changes in the tumor earlier. By improving the precision of tumor detection and monitoring, this technique could lead to more targeted and effective treatment plans for patients.

What evidence suggests that the 18F-DOPA PET/CT scan is effective for brain cancer?

Research has shown that 18F-DOPA PET/CT scans, which participants in this trial will undergo, can aid in managing brain tumors. This imaging method uses a small amount of a radioactive substance to enhance the visibility of tumor activity, assisting in tumor detection. Studies indicate that these scans effectively identify both aggressive and less aggressive gliomas, a type of brain tumor. Combining this scan with regular imaging techniques may improve patient care for those with brain tumors. Although further research is needed, early results suggest promise for enhancing the diagnosis and treatment of brain tumors with this technology. ^{4 6 7 8 9}

Who Is on the Research Team?

Derek R. Johnson, MD

Principal Investigator

Mayo Clinic in Rochester

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

Citations

1. 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.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06667726

An Investigational Scan (18F-DOPA PET/CT) for Improving ... Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors. Detailed Description. PRIMARY ...

3. 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 ...

4. snmmi.org snmmi.org/common/Uploaded%20files/Web/Centers/PET%20Center%20of%20Excellence/FDOPA.pdf

Fluorodopa F-18 b) Brain tumors: 18. F-FDOPA has been used for imaging of brain tumors. It accumulates in both high grade and low grade gliomas. In addition, based on limited ...

5. ejnmmires.springeropen.com ejnmmires.springeropen.com/articles/10.1186/s13550-024-01158-7

A study method using early dynamic acquisition of [ 18 F ... We developed a method for processing 18 F-FDOPA PET/CT in the differential diagnosis between BMP and BRN. The method involves a short (3-second) sampling time.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00556153

[F-18]Fluoro-DOPA PET Imaging of Brain Tumors in Children Tne subjects between ages 5 and 17 years will be studies, to determine if there is increased uptake of [F-18]FDOPA in pediatric brain tumors when compared to ...

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

FLUORODOPA F 18 Injection - accessdata.fda.gov risks: Use smallest dose necessary for imaging and ensure safe handling to protect the patient and healthcare worker from radiation exposure. (5.1). ----------- ...

8. pubchem.ncbi.nlm.nih.gov pubchem.ncbi.nlm.nih.gov/compound/6-_18F_fluoro-L-DOPA

6-(18F)fluoro-L-DOPA | C9H10FNO4 | CID 56494 - PubChem Fluorine F 18 fluorodopa is able to cross the blood-brain barrier and is taken up by brain tumor cells. As uptake is higher in tumor cells, tumors may then be ...

9. 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.