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

Primary Purpose

Lung Neoplasm, Lymphoma, Melanoma

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
uEXPLORER/mCT
mCT/uEXPLORER
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Lung Neoplasm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of California Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

uEXPLORER/mCT

mCT/uEXPLORER

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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).

Full Information

First Posted
July 15, 2020
Last Updated
January 5, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT04478318
Brief Title
Comparison of Imaging Characteristics of uEXPLORER and Conventional PET/CT in Patients With Lung Cancer, Lymphoma, and Melanoma
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Neoplasm, Lymphoma, Melanoma, Fluorodeoxyglucose, Positron-emission Tomography

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
uEXPLORER/mCT
Arm Type
Experimental
Arm 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.
Arm Title
mCT/uEXPLORER
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
uEXPLORER/mCT
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
mCT/uEXPLORER
Intervention Description
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
Primary Outcome Measure Information:
Title
Minimum scan duration on a total-body PET/CT scanner for quality
Description
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.
Time Frame
One imaging visit up to two hours
Secondary Outcome Measure Information:
Title
Minimum scan duration on a total-body PET/CT scanner for tumor recognition
Description
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).
Time Frame
One imaging visit up to two hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and willingness to sign an informed consent form. Ability to adhere to the study visit schedule and all protocol requirements. Men and women ≥18 years of age. Diagnosis or suspected diagnosis of lung cancer, melanoma or lymphoma. Patients who have been referred for a PET/CT scan. Exclusion Criteria: Pregnant women. Claustrophobia. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lorenzo Nardo, MD
Organizational Affiliation
UC Davis Department of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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