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Radiotracer

Total-body PET Imaging for Cancer

N/A
Waitlist Available
Led By Lorenzo Nardo, MD
Research Sponsored by University of California, Davis
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men >18 years old with suspected prostate cancer metastasis who are candidates for initial definitive therapy or with suspected recurrence based on elevated serum PSA level
Persons > 18 years old suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)
Must not have
Adults unable to consent
Recent administration of long-acting somatostatin analogs
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one study imaging visit lasting up to 10 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new ways to improve the EXPLORER, the world's first total-body PET/CT scanner, by using it with three different imaging agents.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on imaging techniques rather than medication or invasive procedures, side effects are minimal but may include discomfort from lying still during scanning and exposure to radiation typical of PET/CT scans.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man over 18 with suspected prostate cancer spread or recurrence, indicated by high PSA levels.
Select...
I am over 18 and have or might have a neuroendocrine tumor that is somatostatin receptor positive.
Select...
I am over 18 and have breast cancer that has come back or spread.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give consent for medical procedures.
Select...
I have recently been treated with long-acting somatostatin analogs.
Select...
I cannot lie on my back for 90 minutes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one study imaging visit lasting up to 10 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and one study imaging visit lasting up to 10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
measure radiotracer avidity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Total-body PET scanExperimental Treatment1 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.

Find a Location

Who is running the clinical trial?

University of California, DavisLead Sponsor
943 Previous Clinical Trials
4,755,672 Total Patients Enrolled
Lantheus Medical ImagingIndustry Sponsor
56 Previous Clinical Trials
4,332,667 Total Patients Enrolled
Lorenzo Nardo, MDPrincipal InvestigatorUniversity of California, Davis
3 Previous Clinical Trials
278 Total Patients Enrolled

Media Library

18F-FES (Radiotracer) Clinical Trial Eligibility Overview. Trial Name: NCT05160480 — N/A
Neuroendocrine Tumors Research Study Groups: Total-body PET scan
Neuroendocrine Tumors Clinical Trial 2023: 18F-FES Highlights & Side Effects. Trial Name: NCT05160480 — N/A
18F-FES (Radiotracer) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05160480 — N/A
~6 spots leftby Sep 2025