Positron Emission Tomography(PET) in Lymphoma Assessment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00887718
First received: April 23, 2009
Last updated: December 17, 2012
Last verified: December 2012

April 23, 2009
December 17, 2012
August 2007
June 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00887718 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Positron Emission Tomography(PET) in Lymphoma Assessment
Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)

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.

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).

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Hodgkin's Lymphoma
  • Non Hodgkin's Lymphoma
Biological: PET Scan
18F-Fluorodeoxyglucose (FDG) injection
Experimental: PET scan for lymphoma assessment
Intervention: Biological: PET Scan
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
103
June 2011
June 2011   (final data collection date for primary outcome measure)

Group A: Newly Diagnosed

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.
  • Post-treatment staging including CT of head and neck, chest, abdomen and pelvis, at 1 - 6 weeks post-therapy.
  • Treated with anthracycline-based chemotherapy, with or without radiation therapy (based on the stage of the disease). For Stage III/IV patients, PET will be done following completion of primary chemotherapy. For stage I/II patients, PET will be done after combined modality therapy, or after chemotherapy alone if this was the primary intention of therapy.
  • Patients with residual mass on CT following primary chemotherapy with either "unconfirmed" CR (>75% decrease in size) or PR (³50% decrease in size), based on International workshop criteria.

Exclusion Criteria: Response Assessment

  • None Curative treatment Intent
  • After initial therapy the response status is: complete response, stable disease, or progressive disease
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00887718
UHN REB 07-0235-C
Yes
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Richard Tsang, MD University Health Network, Princess Margaret Hospital
University Health Network, Toronto
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP