Back to resultsDetection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
Primary Purpose
Lymphoma
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fludeoxyglucose F18
Computed Tomography
Positron emission tomography
Sponsored by
About this trial
This is an interventional diagnostic trial for Lymphoma
Eligibility Criteria
Inclusion Criteria:
- Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.
Exclusion Criteria:
- Pregnant or nursing,
- Uncontrolled diabetes mellitus,
- Active infection,
- Inability to give informed consent or to comply with all study procedures,
- Subjects may be excluded at the discretion of the principal investigator or study team members.
Sites / Locations
- Abramson Cancer Center of the University of Pennsylvania
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Fludeoxyglucose F18 (FDG) PET/CT scans
Arm Description
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
Outcomes
Primary Outcome Measures
Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration
Lesional fluorodeoxyglucose (FDG) uptake is measured by standardized uptake value (SUV). The study compared the percentage of change in maximum SUV over 2 hours (first measure was 60 minutes post-administration and second timepoint was 180 minutes post-administration).
Secondary Outcome Measures
Full Information
NCT ID
NCT01004718
First Posted
October 29, 2009
Last Updated
April 27, 2021
Sponsor
Abramson Cancer Center at Penn Medicine
1. Study Identification
Unique Protocol Identification Number
NCT01004718
Brief Title
Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
Official Title
A Pilot Study to Assess the Feasibility of Detection and Quantification of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using FDG-PET/CT Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
November 5, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abramson Cancer Center at Penn Medicine
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell lymphoma.
Detailed Description
OBJECTIVES:
I. Assess the feasibility of detection and quantification of differences in the temporal and spatial distribution of FDG uptake between lesions of HL and DLBCL.
OUTLINE:
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans 60 and 180 minutes after FDG administration.
After completion of study, patients are followed for 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fludeoxyglucose F18 (FDG) PET/CT scans
Arm Type
Experimental
Arm Description
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
Intervention Type
Radiation
Intervention Name(s)
Fludeoxyglucose F18
Other Intervention Name(s)
18FDG, FDG, Fluorine-18, 2 Fluoro-2-deoxy-D-Glucose, Fludeoxyglucose F18
Intervention Description
Undergo FDG PET/CT scans
Intervention Type
Procedure
Intervention Name(s)
Computed Tomography
Other Intervention Name(s)
tomography, computed
Intervention Description
Undergo FDG PET/CT scans
Intervention Type
Procedure
Intervention Name(s)
Positron emission tomography
Other Intervention Name(s)
FDG-PET, PET, PET scan, tomography, emission computed
Intervention Description
Undergo FDG PET/CT scans
Primary Outcome Measure Information:
Title
Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration
Description
Lesional fluorodeoxyglucose (FDG) uptake is measured by standardized uptake value (SUV). The study compared the percentage of change in maximum SUV over 2 hours (first measure was 60 minutes post-administration and second timepoint was 180 minutes post-administration).
Time Frame
2 hours (between 60 minutes post-administration and 180 minutes post-administration)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.
Exclusion Criteria:
Pregnant or nursing,
Uncontrolled diabetes mellitus,
Active infection,
Inability to give informed consent or to comply with all study procedures,
Subjects may be excluded at the discretion of the principal investigator or study team members.
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
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