Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma

Study Purpose

To determine the minimum scan duration for fluorine-18 positron-emitting radioactive isotope-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET)/computed tomography (CT) scans performed on a total-body PET/CT scanner that results in non-inferior image quality to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner. The subject population will be patients being staged for lung cancer, lymphoma, or melanoma.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Ability to understand and willingness to sign an informed consent form. 2. Ability to adhere to the study visit schedule and all protocol requirements. 3. Men and women ≥18 years of age. 4. Diagnosis or suspected diagnosis of lung cancer, melanoma or lymphoma. 5. Patients who have been referred for a PET/CT scan.

Exclusion Criteria:

1. Pregnant women. 2. Claustrophobia. 3. Any significant medical condition that in the opinion of the investigator would prevent the subject from participating and/or adhering to study related procedures or interfere with subject safety.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04478318
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of California, Davis
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lorenzo Nardo, MD
Principal Investigator Affiliation	UC Davis Department of Radiology
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Enrolling by invitation
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lung Neoplasm, Lymphoma, Melanoma, Fluorodeoxyglucose, Positron-emission Tomography

Arms & Interventions

Arms

Experimental: uEXPLORER/mCT

Each patient will undergo a scan on a total-body PET/CT scanner (uEXPLORER) and then undergo an additional scan on a conventional PET/CT scanner (mCT). The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.

Experimental: mCT/uEXPLORER

Each patient will undergo a scan on a conventional PET/CT scanner (mCT) and then undergo an additional scan on a total-body PET/CT scanner (uEXPLORER) . The first scan will take place 60 minutes after injection with 18F-FDG and the second scan will be 90 minutes after injection with 18F-FDG.

Interventions

Device: - uEXPLORER/mCT

Participants will undergo a total-body PET/CT scan with the uEXPLORER scanner first, followed by a PET/CT scan with the conventional mCT PET/CT scanner.

Device: - mCT/uEXPLORER

Participants will undergo a PET/CT scan with the conventional mCT PET/CT scanner, followed by a total-body PET/CT scan with the uEXPLORER scanner

Contact a Trial Team

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University of California Davis, Sacramento, California

Status

Address

University of California Davis

Sacramento, California, 95817

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