Prostate CancerNCT05160480
A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
An observational study of Prostate Cancer and Breast Cancer, run by University of California, Davis at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Breast Cancer, Neuroendocrine Tumors
- What is being tested?
- Total-body PET imaging
- Type of treatment
- Injection or infusion
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jun 2024to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited by physicians, primary care physicians, radiologists, and research team members who will identify potential participants and notify a research team member to assist with consenting. The research team will also screen potential patients from the oncology clinical schedules. When a potential participant is identified, a member of the research team will contact the referring physician and/or a clinical team member in charge of the patient's care and request permission to contact the patient. If the referring physician/clinical team agrees, a member of the research team will contact the patient.
Who may be able to join
- Persons >18 yo with suspected prostate cancer metastasis
- Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date.
- 68Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3)
- Persons > 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)
- Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.
Who cannot join
- Recent administration of long-acting somatostatin analogs
- Adults unable to consent
- Pregnant/lactating persons
- Prisoners
- Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner
- Uncontrolled claustrophobia
- Any significant medical condition that in the opinion of the investigator would prevent the participant from participating and/or adhering to study related procedures or interfere with participant safety
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UC Davis EXPLORER Molecular Imaging Center
Sacramento, California, 95816
Dana Little, MS, 916-734-7749, dalittle@ucdavis.edu
About this study
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).
- Conditions
- Prostate Cancer, Breast Cancer, Neuroendocrine Tumors
- Being tested
- Total-body PET imaging
- Medical subject headings
- Prostatic Neoplasms, Breast Neoplasms, Neuroendocrine Tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total-body PET imagingDiagnostic test
Total-body PET imaging at different timepoints
| Study group | Role | What they receive |
|---|---|---|
| Total-body PET scan | 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. Receives: Diagnostic Test: Total-body PET imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure radiotracer avidity
measure radiotracer avidity, i.e. standardized uptake value measurements (SUV max and mean) of tumor and normal tissue as a function of time with 18F-PSMA, 18F-FES, 68Ga DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis, patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors, and patients with recurrent or metastatic breast cancer.
Measured: One study imaging visit lasting up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start7 Jun 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Responsible party
- Sponsor
- Investigators
- Lorenzo Nardo, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05160480
- Sponsor's protocol ID
- 1837303
- Other IDs
- EXPLLN21-01
- Status last verified
- Oct 2026
- First submitted
- 2 Dec 2021
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
- ClinicalTrials.gov ID
- NCT05160480
- Acronym / sponsor ID
- 1837303
- Conditions
- Prostate Cancer, Breast Cancer, Neuroendocrine Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Lantheus Medical Imaging
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Total-body PET scan | – | Diagnostic Test: Total-body PET imagingAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited by physicians, primary care physicians, radiologists, and research team members who will identify potential participants and notify a research team member to assist with consenting. The research team will also screen potential patients from the oncology clinical schedules. When a potential participant is identified, a member of the research team will contact the referring physician and/or a clinical team member in charge of the patient's care and request permission to contact the patient. If the referring physician/clinical team agrees, a member of the research team will contact the patient.
Key inclusion criteria (5 listed)
- Persons >18 yo with suspected prostate cancer metastasis
- Prior imaging study (CT, and/or MRI and/or Bone scan and/or Fluciclovine scan) suspicious for metastatic disease, obtained within 4 months from the research scan date.
- 68Ga DOTATATE (n=3) or 64Cu-DOTATATE (n=3)
- Persons > 18 yo suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors (NETs)
- Prior DOTATATE PET/CT scan suspicious for tumor obtained not earlier than 4 months from the research scan date.
Key exclusion criteria (7 listed)
- Recent administration of long-acting somatostatin analogs
- Adults unable to consent
- Pregnant/lactating persons
- Prisoners
- Unable to lie supine for up to 90 minutes at different timepoints in the PET scanner
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Total-body PET imagingTotal-body PET imaging at different timepoints | Diagnostic test | Total-body PET scan |
Primary outcome
measure radiotracer avidity
Time frame: One study imaging visit lasting up to 10 hours
measure radiotracer avidity, i.e. standardized uptake value measurements (SUV max and mean) of tumor and normal tissue as a function of time with 18F-PSMA, 18F-FES, 68Ga DOTATATE in a total-body PET scanner among men with suspected prostate cancer metastasis, patients suspicious for or diagnosed with somatostatin receptor positive neuroendocrine tumors, and patients with recurrent or metastatic breast cancer.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lorenzo Nardo, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Breast Cancer, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Research Team (916-731-9004, research-radiology-som@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure radiotracer avidity (time frame: One study imaging visit lasting up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.