- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00188929
Assessment of Treatment Response Using PET/CT Scanner - Non Hodgkin's Lymphoma
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
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- Princess Margaret Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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 |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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.
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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.
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To assess tumor metabolic activity in non-irradiated areas, if detected, and study its temporal changes during a course of radiation treatment (abscopal response).
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To link the concentration of the biochemical marker lactate dehydrogenase (LDH) to treatment response.
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Richard Tsang, MD, Princess Margaret Hospital, Canada
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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