Infiltration Effect on SUV

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-27

Study Completion Date

2019-02-13

Brief Summary

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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.

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Detailed Description

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Conditions

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Dose Response Relationship, Drug

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Reader will not be informed which scan was infiltrated.

Study Groups

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Infiltration

Repeat F-18 FDG PET

Group Type EXPERIMENTAL

F-18 FDG PET

Intervention Type DIAGNOSTIC_TEST

Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.

Interventions

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F-18 FDG PET

Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No