Clinical trial NCT03320564: Infiltration Effect on SUV
Official title: A Study to Assess the Impact of Moderate/Significant Infiltrations on the Standardized Uptake Values of Target Lesions
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dose Response Relationship, Drug
Keywords: injections, intravenous
fluorodeoxyglucose F-18
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: Lucerno Dynamics, LLC
First posted: 2017-10-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients with a moderate or greater infiltration on a routine F-18 FDG PET will be invited to return for a repeat scan.
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans
timeFrame: Baseline scan and follow up scan within 7 days
Secondary outcomes:
Other outcomes:
measure: Change in Metabolic Tumor Volume of Target Lesions Between Infiltrated and Non-infiltrated Scans
timeFrame: 7 days
measure: Change in Total Lesion Glycolysis of Target Lesions Between Infiltrated and Non-infiltrated Scans
timeFrame: 7 days
measure: Change in Estimated Tumor Stage or Predicted Response to Therapy Between Infiltrated and Non-infiltrated Scans
timeFrame: 7 days
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Health, Department of Radiology
name: Shane C Masters, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Osman MM, Muzaffar R, Altinyay ME, Teymouri C. FDG Dose Extravasations in PET/CT: Frequency and Impact on SUV Measurements. Front Oncol. 2011 Nov 16;1:41. doi: 10.3389/fonc.2011.00041. eCollection 2011.
citation: Silva-Rodriguez J, Aguiar P, Sanchez M, Mosquera J, Luna-Vega V, Cortes J, Garrido M, Pombar M, Ruibal A. Correction for FDG PET dose extravasations: Monte Carlo validation and quantitative evaluation of patient studies. Med Phys. 2014 May;41(5):052502. doi: 10.1118/1.4870979.