Positron Emission Tomography(PET) in Lymphoma Assessment

NCT00887718 | Completed DMC

• 1 other identifier: UHN REB 07-0235-C
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin's Lymphoma; Non Hodgkin's Lymphoma

Keywords

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

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (1)

PET scan for lymphoma assessment

EXPERIMENTAL

Biological: PET Scan

Interventions

PET Scan BIOLOGICAL

18F-Fluorodeoxyglucose (FDG) injection

PET scan for lymphoma assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Hodgkin Disease; Lymphoma, Non-Hodgkin

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Richard Tsang, MD

  University Health Network, Princess Margaret Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2009
• First Posted: April 24, 2009
• Study Start: August 1, 2007
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: December 18, 2012

Record last verified: 2012-12

Locations

CA (1)