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Clinical Trials/NCT00887718
NCT00887718
Completed
Not Applicable

Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)

University Health Network, Toronto1 site in 1 country103 target enrollmentAugust 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Hodgkin's Lymphoma
Sponsor
University Health Network, Toronto
Enrollment
103
Locations
1
Primary Endpoint
To determine:the frequency in which the FDG-PET scan result will change the clinical management of the patient, and to record the intervention instituted within 3 months of the PET scan 2)early relapse rates for PET positive, and PET negative patients.
Status
Completed
Last Updated
13 years ago

Overview

Brief Summary

This study examines the role of a diagnostic test called Positron Emission Tomography (PET) scanning in patients with malignant lymphoma. The primary goal of this study is to find out how well PET scanning can detect malignant (cancerous) lymphoma, and how often this extra information will result in a change of stage of disease, or will result in a change in treatment management plans of patients with lymphoma.

Detailed Description

It is currently unknown whether modifying treatment based on FDG-PET results is appropriate. However, clinicians are increasingly using the FDG-PET result, where obtained, in deciding management. Consequently, it would be premature to mandate PET-based treatment modifications in this protocol. Patients will be treated with existing protocols at the discretion of their treating oncologists, based on available information. Oncologists will be surveyed as to whether FDG-PET scan results could have (or affect patient management, and the intervention will be recorded).

Registry
clinicaltrials.gov
Start Date
August 2007
End Date
June 2011
Last Updated
13 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients \> 18 years of age.
  • Confirmed diagnosis of HL or NHL (any histology).
  • Any Ann Arbor stage.
  • Pre-treatment staging including CT of head and neck, chest, abdomen and pelvis, where there is a minimum one equivocal finding on the scan, affecting the assignment of stage or IPI factor (i.e. stage III/IV vs. stage I/II, or a question of extranodal involvement by disease).
  • Group B: Response Assessment
  • Inclusion Criteria:
  • Patients \> 18 years of age.
  • Confirmed diagnosis of HL or NHL (any histology).
  • Any Ann Arbor stage.
  • Pre-treatment staging including CT neck, chest, abdomen and pelvis. If alternate assessment of the neck done by clinical palpitation, ultrasound, or MRI is negative, CT neck is not mandatory.

Exclusion Criteria

  • Response Assessment
  • None Curative treatment Intent
  • After initial therapy the response status is: complete response, stable disease, or progressive disease

Outcomes

Primary Outcomes

To determine:the frequency in which the FDG-PET scan result will change the clinical management of the patient, and to record the intervention instituted within 3 months of the PET scan 2)early relapse rates for PET positive, and PET negative patients.

Time Frame: 24 months

Secondary Outcomes

  • To:1) describe & quantify potential changes in clinical practice caused by the adoption of FDG-PET scanning 2)correlate FDG-PET scan findings with disease characteristics, traditional standard response criteria, biopsy results, & early clinical outcome.(24 months)

Study Sites (1)

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