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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 is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01004718
First Posted: October 30, 2009
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania
  Purpose
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.

Condition Intervention
Lymphoma Radiation: Fludeoxyglucose F18 Procedure: Computed Tomography Procedure: Positron emission tomography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by Abramson Cancer Center of the University of Pennsylvania:

Primary Outcome Measures:
  • 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 ]
  • Rate of change of lesional FDG uptake (measured by change in SUV)
  • 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

Secondary Outcome Measures:
  • Effect of lesion size (e.g., lesions = 3 cm) on primary outcome variables.
  • Effect of lesion location on primary outcome variables (e.g., nodal vs extranodal)
  • Effect of imaging delay time of PET image acquisition upon number of lymphomatous lesions detected

Estimated Enrollment: 10
Study Start Date: May 2009
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01004718


Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01004718     History of Changes
Other Study ID Numbers: UPCC 21408
NCI-2009-01348
First Submitted: October 29, 2009
First Posted: October 30, 2009
Last Update Posted: September 20, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Lymphoma
Hodgkin Disease
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action