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 currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Abramson Cancer Center of the University of Pennsylvania
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: February 26, 2013
Last verified: February 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: May 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01004718

Contacts
Contact: Stephen Schuster, MD 855-216-0098 PennCancerTrials@emergingmed.com

Locations
United States, Pennsylvania
Abramson Cancer Center of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephen Schuster, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Principal Investigator: Stephen Schuster, MD         
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
  More Information

No publications provided

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
Study First Received: October 29, 2009
Last Updated: February 26, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
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
Deoxyglucose
Fluorodeoxyglucose F18
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Radiopharmaceuticals
Diagnostic Uses of Chemicals

ClinicalTrials.gov processed this record on August 28, 2014