Positron Emission Tomography(PET) in Lymphoma Assessment

Hodgkin's Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00887718
• Other study ID #: UHN REB 07-0235-C
• Status: Completed
• Phase: N/A
• First received: April 23, 2009
• Last updated: December 17, 2012
• Start date: August 2007
• Est. completion date: June 2011

Study information

• Verified date: December 2012
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin
• Non Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No