Infiltration Effect on SUV

March 9, 2022 updated by: Wake Forest University Health Sciences

A Study to Assess the Impact of Moderate/Significant Infiltrations on the Standardized Uptake Values of Target Lesions

A widely used semi-quantitative parameter to assess tumor status is the standardized uptake value (SUV). SUV estimation accuracy can be impacted by many variables. Today there still exists a significant amount of variability in PET/CT results in test and re-test studies. This variability can be introduced by instrumentation and subject-specific factors. Variability reduces image quality and increases the required changes in tumor quantification to reflect real tumor response or progression.

PET/CT scanning process requires that the entire net injected dose of radiolabeled tracer is administered intravenously as a bolus. The quality and quantification of a PET/CT image is highly dependent on the uptake of radiolabeled tracer. Boellaard et al. have indicated infiltrations could potentially underestimate SUV measurements by as much as 50%. Infiltrations and obstructions are not uncommon.

Recent studies using a novel QA/QC tool (LaraTM System) for the radiotracer injection process revealed that current means to detect infiltration do not completely identify all infiltrations/obstructions. Since infiltrations may not be visible in the standard field of view (FOV) and since the impact of a peripheral circulatory obstruction may not be visible even if an injection site is in the FOV, it is possible for reading and treating physicians to be unaware that a patient's image and quantification has been impacted. Additionally, when current means do detect an infiltration, they under-represent the severity because they are not capturing that infiltrations often resolve during the uptake period. As a result, infiltrations or obstructions may cause SUV inaccuracy and could adversely impact staging and tumor assessments.

The purpose of this study will be to characterize the impact of moderate or greater infiltrations on standardized uptake values. Patients experiencing a moderate or greater infiltration on a routine clinical PET scan will be invited to return for a repeat scan with injection performed by specially trained personnel to reduce the risk of repeat infiltration. The two scans will be compared to assess for changes in tumor uptake intensity.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with solid tumors undergoing PET/CT scan who have at least one measurable target lesion and sustain a moderate or greater infiltration.

Exclusion Criteria:

  • Subjects unwilling or unable to tolerate a repeat PET/CT scan.
  • Subjects with meaningful medical intervention between PET/CT scans that would likely impact SUV.
  • Subjects with follow up injection infiltrations that would likely impact the SUV.
  • Pregnant patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Infiltration
Repeat F-18 FDG PET
Diagnostic test: F-18 FDG PET
Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans
Time Frame: Baseline scan and follow up scan within 7 days
Target lesions selected as per PERCIST criteria. These criteria require more space than allowed to explain. Reference J Nucl Med 2009; 50: 122S-150S. DOI: 10.2967/jnumed.108.057307
Baseline scan and follow up scan within 7 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Metabolic Tumor Volume of Target Lesions Between Infiltrated and Non-infiltrated Scans
Time Frame: 7 days
Metabolic tumor volume to be measured using threshold defined in PERCIST criteria
7 days
Change in Total Lesion Glycolysis of Target Lesions Between Infiltrated and Non-infiltrated Scans
Time Frame: 7 days
Total lesion glycolysis is calculated for the same metabolic tumor volume as Outcome 2
7 days
Change in Estimated Tumor Stage or Predicted Response to Therapy Between Infiltrated and Non-infiltrated Scans
Time Frame: 7 days
Response is defined per PERCIST criteria
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

Lucerno Dynamics, LLC

Investigators

  • Principal Investigator: Shane C Masters, MD, PhD, Wake Forest Baptist Health, Department of Radiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 27, 2018

Primary Completion (ACTUAL)

February 13, 2019

Study Completion (ACTUAL)

February 13, 2019

Study Registration Dates

First Submitted

October 19, 2017

First Submitted That Met QC Criteria

October 23, 2017

First Posted (ACTUAL)

October 25, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 18, 2022

Last Update Submitted That Met QC Criteria

March 9, 2022

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00046320
  • LUC-2017-001 (OTHER_GRANT: Lucerno Dynamics, LLC)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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