Infiltration Effect on SUV

NCT03320564 | Terminated Results FDA Device

• 2 other identifiers: IRB00046320LUC-2017-001
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Dose Response Relationship, Drug

Keywords

injections, intravenous; fluorodeoxyglucose F-18

Outcome Measures

Primary Outcomes (1)

• Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans

  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 Outcomes (3)

• Change in Metabolic Tumor Volume of Target Lesions Between Infiltrated and Non-infiltrated Scans

  7 days

• Change in Total Lesion Glycolysis of Target Lesions Between Infiltrated and Non-infiltrated Scans

  7 days

• Change in Estimated Tumor Stage or Predicted Response to Therapy Between Infiltrated and Non-infiltrated Scans

  7 days

Study Arms (1)

Infiltration

EXPERIMENTAL

Repeat F-18 FDG PET

Diagnostic Test: F-18 FDG PET

Interventions

F-18 FDG PET DIAGNOSTIC_TEST

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

Infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• Lucerno Dynamics, LLC: collaborator

Study Sites (1)

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (2)

• 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.

  PMID: 22655246 BACKGROUND

• 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.

  PMID: 24784399 BACKGROUND

Limitations and Caveats

Early study termination due to slow subject accrual with resulting sample size too small for analysis. This was mainly due to improvement in injection techniques and lower than expected extravasation rate.

Results Point of Contact

• Title: Katie Holbrook Bingman
• Organization: Wake Forest Baptist Health

krholbro@wakehealth.edu

336-713-7765

Study Officials

• Shane C Masters, MD, PhD

  Wake Forest Baptist Health, Department of Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Reader will not be informed which scan was infiltrated.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All patients with a moderate or greater infiltration on a routine F-18 FDG PET will be invited to return for a repeat scan.

Study Record Dates

• First Submitted: October 19, 2017
• First Posted: October 25, 2017
• Study Start: August 27, 2018
• Primary Completion: February 13, 2019
• Study Completion: February 13, 2019
• Last Updated: March 18, 2022
• Results First Posted: April 3, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)