Lymphoma, Non-HodgkinPhase 2NCT00188929
Assessment of Treatment Response Using PET/CT Scanner - Non Hodgkin's Lymphoma
A Phase 2 study testing PET Scan with [18F]Fluoro-2-deoxyglucose (FDG) in people with Lymphoma, Non-Hodgkin, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Non-Hodgkin
- What is being tested?
- PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2005to Jul 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Lymphoma, Non-Hodgkin
- Being tested
- PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)
- Medical subject headings
- Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET Scan with [18F]Fluoro-2-deoxyglucose (FDG)Procedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (4)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2005
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Non-HodgkinStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Investigators
- Richard Tsang, MD, Principal investigator, Princess Margaret Hospital, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00188929
- Sponsor's protocol ID
- UHN REB 05-0339-C
- Status last verified
- Aug 2010
- First submitted
- 12 Sep 2005
- Last updated
- 13 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00188929
- Acronym / sponsor ID
- UHN REB 05-0339-C
- Conditions
- Lymphoma, Non-Hodgkin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- Aug 2005
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 16 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET Scan with [18F]Fluoro-2-deoxyglucose (FDG) | Procedure or surgery | – |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Tsang, MD principal investigator
Princess Margaret Hospital, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PET Scan with [18F]Fluoro-2-deoxyglucose (FDG) in people with Lymphoma, Non-Hodgkin, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary 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.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2010.