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

Primary Purpose

Lymphoma, Non-Hodgkin

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphoma, Non-Hodgkin

Eligibility Criteria

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

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)

Sites / Locations

  • Princess Margaret Hospital

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
September 12, 2005
Last Updated
August 12, 2010
Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT00188929
Brief Title
Assessment of Treatment Response Using PET/CT Scanner - Non Hodgkin's Lymphoma
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2010
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Health Network, Toronto
Collaborators
Princess Margaret Hospital, Canada

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non-Hodgkin

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.
Title
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.
Title
To assess tumor metabolic activity in non-irradiated areas, if detected, and study its temporal changes during a course of radiation treatment (abscopal response).
Title
To link the concentration of the biochemical marker lactate dehydrogenase (LDH) to treatment response.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Tsang, MD
Organizational Affiliation
Princess Margaret Hospital, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

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

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