Total-body PET Imaging for Cancer

Overseen By Dana Little, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Must not be taking: Somatostatin analogs

Disqualifiers: Pregnancy, Prisoners, Claustrophobia, others

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

Compensation: Varies

Number of Visits: 1

9 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to test new ways to improve the usefulness of the world's first total-body positron emission tomography (PET)/computed tomography (CT) scanner (EXPLORER) by collecting data from PET scans using one of three different imaging agents: 18F-PSMA; 18F-FES; or, 68Ga DOTATATE. These imaging agents are approved by the FDA to be used for patients diagnosed with prostate cancer (18F-PSMA), neuroendocrine tumor (68Ga DOTATATE), or breast cancer (18F-FES).

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude participants who have recently taken long-acting somatostatin analogs. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the drug 18F-FES, 18F-Fluoroestradiol, FES, 18F-PSMA, 68Ga DOTATATE for cancer treatment?

Research shows that 18F-PSMA and similar tracers are effective in detecting prostate cancer lesions, often outperforming conventional imaging methods. This suggests that these tracers can be useful in identifying cancerous areas, which is crucial for effective treatment planning. ^{1 2 3 4 5}

Is total-body PET imaging for cancer safe for humans?

Research on PET imaging agents like 18F-PSMA and 68Ga-PSMA shows they are generally safe, with the highest radiation dose typically absorbed by the kidneys. These agents have been used in prostate cancer imaging without significant safety concerns. ^{4 6 7 8 9}

How is the drug 18F-FES, 18F-PSMA, 68Ga DOTATATE unique for cancer treatment?

This drug is unique because it uses advanced imaging techniques with PET scans to target specific cancer markers, like PSMA, which helps in better detection and staging of cancer. The use of 18F-labeled compounds allows for higher image quality and wider availability due to their longer half-life, making it easier to distribute and use in various clinical settings. ^{3 10 11 12 13}

Research Team

Lorenzo Nardo, MD

Principal Investigator

University of California, Davis

Eligibility Criteria

This trial is for adults with certain types of cancer: prostate, neuroendocrine tumors, or breast cancer. Participants must have had a previous imaging study within the last 4 months that suggests metastatic disease. Men over 18 suspected of having prostate cancer recurrence based on PSA levels can also join.

Inclusion Criteria

I was diagnosed with ER-positive breast cancer in the last 6 months.

I've had a scan within the last 4 months showing possible cancer spread.

Prior imaging study (CT, US, MRI, bone scan, FDG PET/CT) suspicious for tumor, obtained not earlier than 4 months from the research scan date

Exclusion Criteria

I am unable to give consent for medical procedures.

I haven't taken tamoxifen in the last 8 weeks or fulvestrant in the last 28 weeks.

Prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo a total-body PET scan using one of three FDA-approved radiotracers

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

Treatment Details

Interventions

• 18F-FES
• 18F-PSMA
• 68Ga DOTATATE

Trial Overview The study tests new ways to use the EXPLORER total-body PET/CT scanner with FDA-approved imaging agents (18F-PSMA for prostate cancer, 68Ga DOTATATE for neuroendocrine tumors, and 18F-FES for breast cancer) to improve diagnostic accuracy.

Participant Groups

Group I: Total-body PET scan Experimental Treatment 1 Intervention

All participants will receive a dynamic PET scan for up to 90 minutes. This will be followed by two 30 minutes static PET scans at 3 hours +/-20 minutes and 6 hours +/-20 minutes post injection. Subjects injected with 18F-PSMA or 18F-FES will receive a 40 minute scan at 9 hours +/-20 minutes post injection.

18F-FES is already approved in United States for the following indications:

Approved in United States as 18F-Fluoroestradiol for:

• Estrogen receptor-positive breast cancer

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Lantheus Medical Imaging

Industry Sponsor

Trials

57

Recruited

4,333,000+

Findings from Research

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.

This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. Rowe, SP., Macura, KJ., Mena, E., et al.[2022]

18F-labeled PSMA-targeted PET imaging agents for prostate cancer offer significant advantages over traditional 68Ga-labeled compounds, including better availability in smaller hospitals and potential cost savings due to easier distribution.

These 18F-labeled compounds provide improved image quality with higher positron yield and lower noise, enhancing the detection of subtle lesions and allowing for more flexible imaging protocols, which may lead to better diagnostic accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging. Werner, RA., Derlin, T., Lapa, C., et al.[2023]

The study demonstrated that a comprehensive whole-body 18F-PSMA-1007-PET/MRI protocol is feasible and reproducible for imaging prostate cancer in eight high-risk patients, effectively detecting dominant lesions and providing complementary staging information.

The results showed strong correlation between SUVmean values from PET/CT and PET/MRI, indicating that this combined imaging approach can enhance the accuracy of prostate cancer assessment while minimizing artifacts, thus improving patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. Freitag, MT., Kesch, C., Cardinale, J., et al.[2019]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Intraindividual comparison of [68 Ga]-Ga-PSMA-11 and [18F]-F-PSMA-1007 in prostate cancer patients: a retrospective single-center analysis. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Multiparametric dynamic whole-body PSMA PET/CT using [68Ga]Ga-PSMA-11 and [18F]PSMA-1007. [2023]

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

Radiohybrid Ligands: A Novel Tracer Concept Exemplified by 18F- or 68Ga-Labeled rhPSMA Inhibitors. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Time after Synthesis and Time after Injection Do Not Affect Diagnostic Quality of [18F]F-PSMA 1007 PET. [2022]

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

PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]

6. China pubmed.ncbi.nlm.nih.gov

Keeping up with the prostate-specific membrane antigens (PSMAs): an introduction to a new class of positron emission tomography (PET) imaging agents. [2020]

7. Germany pubmed.ncbi.nlm.nih.gov

Biodistribution and radiation dosimetry of [18F]-JK-PSMA-7 as a novel prostate-specific membrane antigen-specific ligand for PET/CT imaging of prostate cancer. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Biodistribution and internal radiation dosimetry of a companion diagnostic radiopharmaceutical, [68Ga]PSMA-11, in subcutaneous prostate cancer xenograft model mice. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Intra-individual comparison of 68Ga-PSMA-11 and 18F-DCFPyL normal-organ biodistribution. [2021]

10. Australia pubmed.ncbi.nlm.nih.gov

18F-Labeled, PSMA-Targeted Radiotracers: Leveraging the Advantages of Radiofluorination for Prostate Cancer Molecular Imaging. [2023]

11. Germany pubmed.ncbi.nlm.nih.gov

Simultaneous whole-body 18F-PSMA-1007-PET/MRI with integrated high-resolution multiparametric imaging of the prostatic fossa for comprehensive oncological staging of patients with prostate cancer: a pilot study. [2019]

12. Germany pubmed.ncbi.nlm.nih.gov

Combined [68 Ga]Ga-PSMA-11 and low-dose 2-[18F]FDG PET/CT using a long-axial field of view scanner for patients referred for [177Lu]-PSMA-radioligand therapy. [2023]

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

Synthesis and Preclinical Characterization of the PSMA-Targeted Hybrid Tracer PSMA-I&F for Nuclear and Fluorescence Imaging of Prostate Cancer. [2020]