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.
Trial 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. Read more about this study
- 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
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.
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Lucerno Dynamics, LLC
- Responsible party
- Sponsor
- Investigators
- Shane C Masters, MD, PhD, Principal investigator, Wake Forest Baptist Health, Department of Radiology
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 22655246Silva-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
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.
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 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
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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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; AzTrials last refreshed its copy on 28 Oct 2026.