Positron Emission Tomography(PET) in Lymphoma Assessment

Sponsor
University Health Network, Toronto (Other)
Overall Status
Completed
CT.gov ID
NCT00887718
Collaborator
(none)
103
1
1
46
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: PET Scan
N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
103 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Positron Emission Tomography for Staging, and Treatment Assessment of Response in Lymphomas (the Pet-star Lymphoma Study)
Study Start Date :
Aug 1, 2007
Actual Primary Completion Date :
Jun 1, 2011
Actual Study Completion Date :
Jun 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: PET scan for lymphoma assessment

Biological: PET Scan
18F-Fluorodeoxyglucose (FDG) injection

Outcome Measures

Primary Outcome Measures

  1. 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. [24 months]

Secondary Outcome Measures

  1. 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]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Health Network, Princess Margaret Hospital Toronto Ontario Canada M5G 2M9

Sponsors and Collaborators

  • University Health Network, Toronto

Investigators

  • Principal Investigator: Richard Tsang, MD, University Health Network, Princess Margaret Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00887718
Other Study ID Numbers:
  • UHN REB 07-0235-C
First Posted:
Apr 24, 2009
Last Update Posted:
Dec 18, 2012
Last Verified:
Dec 1, 2012
Keywords provided by University Health Network, Toronto
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 18, 2012