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Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01004718
First received: October 29, 2009
Last updated: October 10, 2014
Last verified: October 2014

October 29, 2009
October 10, 2014
May 2009
July 2013   (final data collection date for primary outcome measure)
  • Amount of lesional FDG uptake (assessed by qualitative assessment, standardized uptake value (SUV), and lesion to background uptake ratios) [ Time Frame: At 60 and 180 minutes after FDG administration ] [ Designated as safety issue: No ]
  • Rate of change of lesional FDG uptake (measured by change in SUV) [ Designated as safety issue: No ]
  • Characteristics of lesional SUV frequency histograms (e.g., mean, standard deviation, full-width-half-maximum (FWHM), etc.) and/or lesional SUV heterogeneity maps, along with changes in these characteristics [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01004718 on ClinicalTrials.gov Archive Site
  • Effect of lesion size (e.g., lesions = 3 cm) on primary outcome variables. [ Designated as safety issue: No ]
  • Effect of lesion location on primary outcome variables (e.g., nodal vs extranodal) [ Designated as safety issue: No ]
  • Effect of imaging delay time of PET image acquisition upon number of lymphomatous lesions detected [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
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

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lymphoma
  • Radiation: Fludeoxyglucose F18
    Undergo FDG PET/CT scans
    Other Name: 18FDG, FDG, Fluorine-18, 2 Fluoro-2-deoxy-D-Glucose, Fludeoxyglucose F18
  • Procedure: Computed Tomography
    Undergo FDG PET/CT scans
    Other Name: tomography, computed
  • Procedure: Positron emission tomography
    Undergo FDG PET/CT scans
    Other Name: FDG-PET, PET, PET scan, tomography, emission computed
Experimental: Arm I
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
Interventions:
  • Radiation: Fludeoxyglucose F18
  • Procedure: Computed Tomography
  • Procedure: Positron emission tomography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
July 2013
July 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01004718
UPCC 21408, NCI-2009-01348
Yes
Abramson Cancer Center of the University of Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Not Provided
Not Provided
Abramson Cancer Center of the University of Pennsylvania
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP