Dose Response Relationship, DrugNCT03320564

Infiltration Effect on SUV

A study testing F-18 FDG PET in people with Dose Response Relationship, Drug, run by Wake Forest University Health Sciences at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Dose Response Relationship, Drug
What is being tested?: F-18 FDG PET
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 27 Aug 2018to 13 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: 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.

Conditions: Dose Response Relationship, Drug
Being tested: F-18 FDG PET
Keywords: injections, intravenous, fluorodeoxyglucose F-18

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

F-18 FDG PETDiagnostic test
Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.

Study groups in NCT03320564
Study group	Role	What they receive
Infiltration	Experimental	Repeat F-18 FDG PET Receives: Diagnostic Test: F-18 FDG PET

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: Baseline scan and follow up scan within 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Aug 201813 Feb 2019

First posted25 Oct 2017
Study start27 Aug 2018
Primary completion13 Feb 2019
Study completion13 Feb 2019

Why it stopped: Recruitment slow due to improved extravasation rate.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Dose Response Relationship, DrugStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03320564
Sponsor's protocol ID: IRB00046320
Other IDs: LUC-2017-001
Status last verified: Mar 2019
First submitted: 19 Oct 2017
Last updated: 18 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 22655246
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.
PubMed 24784399

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Study to Assess the Impact of Moderate/Significant Infiltrations on the Standardized Uptake Values of Target Lesions
ClinicalTrials.gov ID: NCT03320564
Acronym / sponsor ID: IRB00046320
Conditions: Dose Response Relationship, Drug
Keywords: injections, intravenous, fluorodeoxyglucose F-18
Study type: Interventional
Recruitment status: TerminatedReason stopped: Recruitment slow due to improved extravasation rate.
Enrolment: 2 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Collaborators: Lucerno Dynamics, LLC
Study start: 27 Aug 2018 (actual)
Primary completion: 13 Feb 2019 (actual)
Study completion: 13 Feb 2019 (actual)
First posted: 25 Oct 2017 (actual)
Results: Posted 3 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Infiltration	Experimental	Diagnostic Test: F-18 FDG PETRepeat F-18 FDG PET

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
F-18 FDG PETRepeat scan performed by specially trained staff to reduce risk of repeat infiltration.	Diagnostic test	Infiltration

Primary outcome

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

Results and safety

Results posted to the registry on 3 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infiltration	2	1

Primary outcome: Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans

Time frame: Baseline scan and follow up scan within 7 days. Mean (Standard Deviation). Unit: SUV (dimensionless)

Measure	Infiltration n = 1
Value	3.6 (1.4)

Population analysed: Up to 5 target lesions measured per participant (4 for this subject) with mean and standard deviation reported below.

Adverse events

Time frame: All subjects assessed from enrollment to study closure. For the subject with data recorded, approximately 5 months between enrollment and study closure.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infiltration	1 of 1 (100%)	0 of 1 (0%)	0 of 1

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22655246Osman 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.
Background: PubMed 24784399Silva-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.
Individual participant dataSharing planned: No

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RecruitingPhase 1
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shane C Masters, MD, PhD principal investigator

Wake Forest Baptist Health, Department of Radiology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing F-18 FDG PET in people with Dose Response Relationship, Drug, run by Wake Forest University Health Sciences at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in SUVpeak of Target Lesions Between Infiltrated and Non-infiltrated Scans (time frame: Baseline scan and follow up scan within 7 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03320564, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2022.