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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)

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.
 
ClinicalTrials.gov Identifier: NCT01004718
Recruitment Status : Completed
First Posted : October 30, 2009
Last Update Posted : April 17, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Lymphoma Radiation: Fludeoxyglucose F18 Procedure: Computed Tomography Procedure: Positron emission tomography Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
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
Study Start Date : May 2009
Actual Primary Completion Date : July 2013
Actual Study Completion Date : November 5, 2014


Arm Intervention/treatment
Experimental: Fludeoxyglucose F18 (FDG) PET/CT scans
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




Primary Outcome Measures :
  1. Amount of lesional FDG uptake [ Time Frame: 3 months ]
    Assessed by qualitative assessment

  2. Amount of lesional FDG uptake [ Time Frame: 3 months ]
    Assessed by standardized uptake value (SUV)

  3. Amount of lesional FDG uptake [ Time Frame: 3 months ]
    Assessed by lesion to background update ratios at 60 and 180 minutes.

  4. Rate of change of lesional FDG uptake [ Time Frame: 3 months ]
    Measured by change in standardized uptake value (SUV) over time.

  5. Characteristics of lesional standardized uptake value (SUV) [ Time Frame: 3 months ]
    Assessed by frequency histograms and/or heterogeneity maps along with changes in these characteristics.


Secondary Outcome Measures :
  1. Effect of lesion size (e.g., lesions = 3 cm) on primary outcome variables. [ Time Frame: 3 months ]
    Less than 3cm versus greater than or equal to 3cm impact, if any.

  2. Effect of lesion location on primary outcome variables (e.g., nodal vs extranodal) [ Time Frame: 3 months ]
    Nodal versus extranodal impact, if any.

  3. Effect of imaging delay time of PET image acquisition upon number of lymphomatous lesions detected [ Time Frame: 3 months ]
    Effect on number of lymphomatos lesions detected, if any.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

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
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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
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01004718    
Other Study ID Numbers: UPCC 21408
NCI-2009-01348
First Posted: October 30, 2009    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Hodgkin Disease
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
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antiviral Agents
Anti-Infective Agents