Assessment of Treatment Response Using PET/CT Scanner - Non Hodgkin's Lymphoma

August 12, 2010 updated by: University Health Network, Toronto

Spatio-temporal Response of Non-Hodgkin's Lymphoma to External Beam Radiation Therapy Measuring 18F-Fluorodeoxyglucose (FDG) Uptake Using a Combined PET/CT Scanner: A Pilot Study

In this study the treatment process will be closely monitored using a novel imaging technology, a PET/CT scanner. PET stands for Positron Emission Tomography and in this case it will be combined with a conventional x-ray Computerized Tomography (CT) scan. This is not a study of any particular form of treatment. The treatment you receive will be the most appropriate standard treatment whether you are in the study or not.

The goal of radiation therapy is to deliver a given amount of radiation dose to the area where there is a lymphoma tumour. We are doing this study to see which part of the tumour reacts to the radiation treatment, and which part does not react, by monitoring the progress of your treatment with a combined PET/CT scan. In particular, changes of the size and shape of the tumour that occur during the treatment can be detected and will be visible on the images. These images will be thoroughly analysed. The ability of the PET/CT scanner to detect these changes during a course of radiation treatment will be the subject of this study. We will also be able to see if this information will eventually relate to or predict whether lymphoma tumours will be completely eradicated by the treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologic diagnosis of NHL:Any histology
  • Stage I-IV
  • Measurable disease by CT scan (gross disease measuring at least 2 cm in any one dimension)
  • Planned radiation dose prescription >=30 gy, >=20 fractions, >=3weeks duration
  • Informed consent
  • Previous chemotherapy is allowed, provided the above eligibility criteria are me

Exclusion Criteria:

  • To minimize effect from breathing motion, patients presenting with parenchymal lung tumours and tumours involving liver and stomach will be excluded
  • Concurrent systemic chemotherapy (glucocorticoids when used alone is allowed)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To quantify spatial and temporal treatment response to radiation therapy in patients with NHL using the co-registered CT and FDG-PET images and assess this response with temporal geometric models.

Secondary Outcome Measures

Outcome Measure
To assess the feasibility to spatially correlate the abnormalities on the CT image to the FDG uptake on the co-registered PET image using the geometric models.
To determine if the inclusion of a GTV based upon PET images alters (1) the treatment plan based on the initial planning CT; and (2) if GTVs based on CT or PET differ for adaptive plans.
To assess tumor metabolic activity in non-irradiated areas, if detected, and study its temporal changes during a course of radiation treatment (abscopal response).
To link the concentration of the biochemical marker lactate dehydrogenase (LDH) to treatment response.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Richard Tsang, MD, Princess Margaret Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 16, 2005

Study Record Updates

Last Update Posted (Estimate)

August 13, 2010

Last Update Submitted That Met QC Criteria

August 12, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 05-0339-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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