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Completed

NCT Number: NCT00887718

Positron Emission Tomography(PET) in Lymphoma Assessment

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET Scan

Biological

18F-Fluorodeoxyglucose (FDG) injection

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.

    Time frame: 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.

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Apr 24, 2009
Registry last updated
Dec 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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