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

University of California (UC) Davis

Status: Invitation-only

Conditions: Melanoma; Fluorodeoxyglucose; Positron-emission Tomography; Lymphoma; Lung Neoplasm

Treatments: Device: uEXPLORER/mCT; Device: mCT/uEXPLORER

Study type: Interventional

Funder types: Other

Identifiers

NCT04478318

1506448

CCRD039 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

uEXPLORER/mCT

Experimental group

Description:

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.

Treatment:

Device: uEXPLORER/mCT

mCT/uEXPLORER

Experimental group

Description:

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.

Treatment:

Device: mCT/uEXPLORER