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

Not Applicable

• Conditions: Lung Neoplasm; Melanoma; Lymphoma; Fluorodeoxyglucose; Positron-emission Tomography
• Interventions: Device: uEXPLORER/mCT; Device: mCT/uEXPLORER

• Registration Number: NCT04478318
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-07-15
• Study First Submitted QC: 2020-07-15
• Study First Posted: 2020-07-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
uEXPLORER/mCT	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.
mCT/uEXPLORER	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.

Primary Outcome Measures

Name	Time	Method
Minimum scan duration on a total-body PET/CT scanner for quality	One imaging visit up to two hours	To determine the minimum scan duration for 18F-FDG PET/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 over 20 minutes.

Secondary Outcome Measures

Name	Time	Method
Minimum scan duration on a total-body PET/CT scanner for tumor recognition	One imaging visit up to two hours	To determine the minimum scan duration for 18F-FDG PET/CT scans performed on a total-body PET/CT scanner that results in non-inferior tumor conspicuity to 18F-FDG PET/CT scans performed on a conventional PET/CT scanner over 20 minutes (with an additional 2 minutes of data used for optimization purposes).

Trial Locations

Locations (1)

University of California Davis; 🇺🇸 Sacramento, California, United States