NCT04478318

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jun 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Jun 2020Jun 2026

Study Start

First participant enrolled

June 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2020

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 17, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

March 10, 2026

Status Verified

January 1, 2026

Enrollment Period

5.1 years

First QC Date

July 15, 2020

Last Update Submit

March 9, 2026

Conditions

LymphomaMelanomaFluorodeoxyglucosePositron-emission TomographyLung Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Minimum scan duration on a total-body PET/CT scanner for tumor recognition

    One imaging visit up to two hours

Study Arms (2)

uEXPLORER/mCT

EXPERIMENTAL

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.

Device: uEXPLORER/mCT

mCT/uEXPLORER

EXPERIMENTAL

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.

Device: mCT/uEXPLORER

Interventions

uEXPLORER/mCTDEVICE

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.

uEXPLORER/mCT
mCT/uEXPLORERDEVICE

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

mCT/uEXPLORER

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California Davis

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Lung NeoplasmsLymphomaMelanoma

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lorenzo Nardo, MD

    UC Davis Department of Radiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2020

First Posted

July 20, 2020

Study Start

June 1, 2020

Primary Completion

July 17, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

March 10, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)