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Positron Emission Tomography(PET) in Lymphoma Assessment

Primary Purpose

Hodgkin's Lymphoma, Non Hodgkin's Lymphoma

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

PET Scan

About this trial

This is an interventional diagnostic trial for Hodgkin's Lymphoma focused on measuring PET scan and Hodgkin's Lymphoma, PET scan and Non Hodgkin's Lymphoma, PET scan

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

PET scan for lymphoma assessment

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT00887718

First Posted

April 23, 2009

Last Updated

December 17, 2012

Sponsor

University Health Network, Toronto

1. Study Identification

Unique Protocol Identification Number

NCT00887718

Brief Title

Positron Emission Tomography(PET) in Lymphoma Assessment

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2012

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Health Network, Toronto

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hodgkin's Lymphoma, Non Hodgkin's Lymphoma

Keywords

PET scan and Hodgkin's Lymphoma, PET scan and Non Hodgkin's Lymphoma, PET scan

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

103 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PET scan for lymphoma assessment

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

PET Scan

Intervention Description

18F-Fluorodeoxyglucose (FDG) injection

Primary Outcome Measure Information:

Title

Time Frame

24 months

Secondary Outcome Measure Information:

Title

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Richard Tsang, MD

Organizational Affiliation

University Health Network, Princess Margaret Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Health Network, Princess Margaret Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 2M9

Country

Canada

12. IPD Sharing Statement

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Positron Emission Tomography(PET) in Lymphoma Assessment

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