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

Lymphoma Clinical Trial

Official title:

Quantitative Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma Undergoing Standard-of-Care FDG-PET/CT for Initial Staging

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04478318
• Other study ID #: 1506448
• Secondary ID: CCRD039
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2025

Study information

• Verified date: January 2024
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 180
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Fluorodeoxyglucose
• Lung Neoplasm
• Lung Neoplasms
• Lymphoma
• Melanoma
• Positron-emission Tomography

Intervention

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.
• 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

Locations

Country	Name	City	State
United States	University of California Davis	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Minimum scan duration on a total-body PET/CT scanner for quality	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.	One imaging visit up to two hours
Secondary	Minimum scan duration on a total-body PET/CT scanner for tumor recognition	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).	One imaging visit up to two hours