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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests ways to enhance the utility of a new total-body PET/CT scanner for diagnosing certain cancers. It employs various imaging agents, such as 18F-FES (also known as 18F-Fluoroestradiol or FES), to improve visualization of prostate cancer, neuroendocrine tumors, or breast cancer. Suitable candidates include those with suspected prostate cancer or diagnosed neuroendocrine tumors, particularly if previous scans indicated potential issues. Participants will undergo a series of PET scans over several hours to gather data. As a Phase 2 trial, this research measures the effectiveness of the imaging agents in an initial, smaller group, allowing participants to contribute to advancements in cancer diagnostics.

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 prior data suggests that this total-body PET/CT scanner is safe for cancer imaging?

A previous study found 18F-FES to be safe, with only minor pain at the injection site reported by some patients. Research also shows that 18F-FES is approved for use in breast cancer patients, suggesting its safety for humans.

Studies on 18F-PSMA indicate its safety for imaging prostate cancer. The procedure uses low levels of radioactivity, primarily affecting the kidneys, which suggests it is generally well-tolerated.

Research highlights that 68Ga-DOTATATE does not cause significant side effects and involves less radiation than other imaging methods, making it a safe choice for patients with neuroendocrine tumors.

All three imaging agents—18F-FES, 18F-PSMA, and 68Ga-DOTATATE—are FDA-approved for specific types of cancer, indicating they are generally considered safe for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about total-body PET imaging for cancer because it offers a comprehensive view of cancer spread in the body, with potential to improve diagnosis and treatment planning. Unlike traditional imaging methods that focus on specific areas, total-body PET scans use advanced tracers like 18F-FES, 18F-PSMA, and 68Ga DOTATATE to highlight cancer activity throughout the entire body, providing a more complete picture in one session. This approach could lead to faster, more accurate assessments and help tailor treatments to individual patient needs, potentially improving outcomes.

What evidence suggests that this trial's imaging agents could be effective for cancer?

Research has shown that certain imaging agents, such as 18F-FES, 18F-PSMA, and 68Ga DOTATATE, effectively detect specific types of cancer. In this trial, participants will undergo a total-body PET scan using one of these agents. The 18F-FES agent excels at identifying ER-positive breast cancer and aids doctors in assessing and predicting treatment effectiveness. The 18F-PSMA agent accurately detects prostate cancer and outperforms other imaging methods. Meanwhile, 68Ga DOTATATE effectively identifies neuroendocrine tumors and often prompts changes in treatment plans for about 41% of patients. The FDA has approved these imaging agents for these specific cancers, underscoring their reliability in diagnosis and management. ^{2 6 7 8 9}

Who Is on the Research Team?

Lorenzo Nardo, MD

Principal Investigator

University of California, Davis

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12110083/

The Role of [18F]FES PET/CT in Breast Cancer Management [18F]FES PET/CT demonstrated high sensitivity (81–94%) and specificity (78–95%) in detecting ER-positive lesions. It provided a real-time, whole ...

2. jnm.snmjournals.org jnm.snmjournals.org/content/66/supplement_1/251561

Initial Institutional Experience with 18F-FES PET/CT in ... FDA approved in 2020, FES PET/CT evaluates ER status, predicts response to endocrine therapy, and clarifies ambiguous staging or restaging cases ...

3. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/rg.220143

18F-Fluoroestradiol: Current Applications and Future ... FES is a PET radiotracer that targets the ER and was recently approved for use in patients with metastatic ER-positive breast cancer in France ...

4. ascopubs.org ascopubs.org/doi/abs/10.1200/JCO.2025.43.16_suppl.1059

Clinical utility of [18F]fluoroestradiol (FES) PET/CT to guide ... FES PET/CT results led to 25/45 patients avoiding additional tests (20 biopsies, 5 scans) and 7/45 patients receiving further testing (4 ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12162187/

Fluoroestradiol PET (FES-PET) and [18 ... This study examines the combination of FES-PET and FDG-PET as complementary imaging for detection of metastatic ILC.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8560320/

Safety and Effectiveness of F-18 Fluoroestradiol Positron ... Results of the evaluation indicated that the F-18 FES PET/CT test was safe because patients who reported pain in the injection site in the analyzed articles are ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT05088785

Dynamic and Test-retest Whole Body [18F]FES PET ... Also called a data safety and monitoring board, or DSMB. Early Phase 1 (formerly listed as Phase 0). A phase of research used to describe exploratory trials ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10912074/

Dynamic whole-body [18F]FES PET/CT increases lesion ... D-WB [18F]FES PET/CT scans can be used for direct reconstruction of parametric K i images, with superior lesion visibility and K i values ...

9. ejhi.springeropen.com ejhi.springeropen.com/articles/10.1186/s41824-023-00176-3

Head-to-head comparison of 18F-FDG and 18F-FES PET ... This study aimed to compare the diagnostic performance of 18 F-FDG and 18 F-FES PET/CT in the initial staging of ER-positive breast cancer.