Clinical trial NCT05160480: A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
Official title: A Pilot Study of Total-body PET Using FDA-approved Radiotracers Beyond 18F-FDG
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prostate Cancer
Breast Cancer
Neuroendocrine Tumors
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Lantheus Medical Imaging
First posted: 2021-12-16
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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. 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).


Eligibility criteria: 18F-PSMA (n=3) and 68Ga-PSMA (n=3)

Inclusion criteria:

* 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)

Inclusion Criteria:

* 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.

Exclusion Criteria:

• Recent administration of long-acting somatostatin analogs

Exclusion Criteria for all participants:

* 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

Primary outcomes:
measure: measure radiotracer avidity
timeFrame: One study imaging visit lasting up to 10 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis EXPLORER Molecular Imaging Center
state: California
Study officials:
affiliation: University of California, Davis
name: Lorenzo Nardo, MD
role: PRINCIPAL_INVESTIGATOR
References: