Lung CancerNCT01789892
Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
A study testing methylprednisolone, fludeoxyglucose F 18 and positron emission tomography in people with Lung Cancer, run by Ohio State University Comprehensive Cancer Center.
Trial summary
The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- methylprednisolone, fludeoxyglucose F 18 and positron emission tomography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
- Undergone clinical FDG PET/CT scan within 14 days of enrollment
Who cannot join
- Prisoners
- Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose > 180 mg/dl)
- Serious infection within 14 days of enrollment
- Known hypersensitivity to methylprednisolone
- Viral skin lesions
- Immunocompromised ANC(absolute neutrophil count < 1000/microliter)
Show all 11Show fewer
- Pregnant/nursing
- History of tuberculosis or systemic fungal disease
- History of steroid psychosis
- Current peptic ulcer disease or diverticulitis
- Corticosteroid use within 14 days of enrollment (including inhaled steroids)
About this study
Official title: FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation
Read the detailed description
PRIMARY OBJECTIVES:
- To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 [FDG[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.
OUTLINE:
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.
After completion of study treatment, patients are followed up for 2 years.
- Conditions
- Lung Cancer
- Being tested
- methylprednisolone, fludeoxyglucose F 18, positron emission tomography, computed tomography
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Depo-Medrol, Medrol, MePRDL, Solu-Medrol
Given IV
fludeoxyglucose F 18Radiation
Also called 18FDG, FDG
Undergo FDG PET/CT scan
positron emission tomographyProcedure or surgery
Also called FDG-PET, PET, PET scan, tomography, emission computed
Undergo FDG PET/CT scan
computed tomographyProcedure or surgery
Also called tomography, computed
Undergo FDG PET/CT scan
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (methylprednisolone and FDG PET/CT scan) | Experimental | Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan. Receives: Drug: methylprednisolone; Radiation: fludeoxyglucose F 18; Procedure: positron emission tomography; Procedure: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous standardized uptake values (SUV)
The SUV on the first and second PET scans will be recorded and summarized on a receiver operating characteristic (ROC) curve. We will explore the ROC curve for percent change in SUV or uptake ratio from the first to the second scan. We will explore thresholds for SUV and uptake values on the ROC curve by determining the values of acceptable combinations of true positive fractions (TPF) and false positive fractions (FPFs). We will use regression methods to adjust for possible confounding patient demographics, disease severity and disease history.
Measured: Within 1-14 days of first scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startJun 2011
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: no patient accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Barker, MD, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789892
- Sponsor's protocol ID
- OSU-10012
- Other IDs
- NCI-2012-00530
- Status last verified
- Jun 2018
- First submitted
- 8 Feb 2013
- Last updated
- 28 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone
- ClinicalTrials.gov ID
- NCT01789892
- Acronym / sponsor ID
- OSU-10012
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no patient accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation
Detailed description
PRIMARY OBJECTIVES:
- To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 [FDG[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.
OUTLINE:
Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.
After completion of study treatment, patients are followed up for 2 years.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (methylprednisolone and FDG PET/CT scan) | Experimental | Drug: methylprednisolone, Radiation: fludeoxyglucose F 18, Procedure: positron emission tomography, Procedure: computed tomographyWithin 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)
- Undergone clinical FDG PET/CT scan within 14 days of enrollment
Key exclusion criteria (11 listed)
- Prisoners
- Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose > 180 mg/dl)
- Serious infection within 14 days of enrollment
- Known hypersensitivity to methylprednisolone
- Viral skin lesions
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 |
|---|---|---|
| methylprednisoloneAlso: Depo-Medrol, Medrol, MePRDL, Solu-MedrolGiven IV | Drug | Diagnostic (methylprednisolone and FDG PET/CT scan) |
| fludeoxyglucose F 18Also: 18FDG, FDGUndergo FDG PET/CT scan | Radiation | Diagnostic (methylprednisolone and FDG PET/CT scan) |
| positron emission tomographyAlso: FDG-PET, PET, PET scan, tomography, emission computedUndergo FDG PET/CT scan | Procedure or surgery | Diagnostic (methylprednisolone and FDG PET/CT scan) |
| computed tomographyAlso: tomography, computedUndergo FDG PET/CT scan | Procedure or surgery | Diagnostic (methylprednisolone and FDG PET/CT scan) |
Primary outcome
Continuous standardized uptake values (SUV)
Time frame: Within 1-14 days of first scan
The SUV on the first and second PET scans will be recorded and summarized on a receiver operating characteristic (ROC) curve. We will explore the ROC curve for percent change in SUV or uptake ratio from the first to the second scan. We will explore thresholds for SUV and uptake values on the ROC curve by determining the values of acceptable combinations of true positive fractions (TPF) and false positive fractions (FPFs). We will use regression methods to adjust for possible confounding patient demographics, disease severity and disease history.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
- JameslineLink provided by the sponsor.
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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.
David Barker, MD principal investigator
Ohio State University Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing methylprednisolone, fludeoxyglucose F 18 and positron emission tomography in people with Lung Cancer, run by Ohio State University Comprehensive Cancer Center.
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 2 inclusion and 11 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: withdrawn, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Continuous standardized uptake values (SUV) (time frame: Within 1-14 days of first scan). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2018.