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:
Abramson Cancer Center of the University of Pennsylvania
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
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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 May 19, 2013