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.
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
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
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 23, 2014