Non-Small Cell Lung CancerEarly Phase 1NCT00221169
Role of PET CT in Determining Target Volumes in Radiation Therapy for Lung Cancer
A Early Phase 1 study testing Surgical resection in people with Non-Small Cell Lung Cancer, run by Toronto Sunnybrook Regional Cancer Centre at 2 sites in Canada.
Trial summary
Radiation therapy is an important part of the treatment for lung cancer when treatment intent is for cure. Radiation is a local modality of treatment, that is, it only treats the area that the radiation can target. Therefore it is critical to be able to visualize all the areas of tumor involvement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Small Cell Lung Cancer
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesCanada
- Study dates
- Oct 2005to Jan 2009
- Phase
- Early Phase 1
- 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
- Surgically resectable non-small cell lung cancer
- Companion clinical trial to OCOG PET Lung trials
Who cannot join
- Unresectable non-small cell lung cancer
- Unable to undergo PET CT evaluation
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Toronto Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N3M5
About this study
Official title: Can PET CT Coregistration Imaging Adequately Determine the Gross Tumor Volume and Microscopic Extension in Non-Small Cell Lung Cancer Patients for Radical Radiation Therapy?
Radiation therapy is an important part of the treatment for lung cancer when treatment intent is for cure. Radiation is a local modality of treatment, that is, it only treats the area that the radiation can target. Therefore it is critical to be able to visualize all the areas of tumor involvement. With current imaging tests such as computed tomography scans (CT), the scans may not be sensitive enough to detect all areas of cancer involvement but with newer imaging tests, such as positron emission tomography (PET), the investigators may be able to better target all the tumor that the CT scan may miss. There are two clinical trials being conducted by the Ontario Clinical Oncology Group (OCOG)looking at PET in lung cancer. This proposal is a companion study to the OCOG PET lung trials. In brief, this study will evaluate the ability of CT alone versus combined PET CT imaging to determine the size of the tumor (or gross tumor volume) along with the tiny extensions of cancer cells (or microscopic extension). The gross tumor volume and its extension as determined by CT or PET CT will then be compared to measurements made on the surgically removed tumor. Treatment with radiation therapy must include all the gross tumor and its extension in order to be successful for cure. If the radiation treatment does not treat all the identified tumor then the chance for cure is lost. There have only been two previous reports of the ability of CT to determine the gross tumor volume and its extension. There are no similar reports using PET CT. This study will be the first of its kind to evaluate how accurate PET CT can be in detecting the gross tumor and its microscopic extension using the surgically removed tumor measurements as the gold standard. If PET CT is able to more accurately determine the tumor volume including its microscopic extension, then this will help oncologists to better treat lung cancer using more accurate radiation treatment volumes.
Read the detailed description
Radiation therapy is an important component in the curative treatment of non-small cell lung cancer. Targeting of the gross tumor has been facilitated by the use of CT simulation allowing for more accurate delineation of the tumor. In addition multi-modality imaging combining functional and anatomical information have allowed for further refinement in the treatment planning process with significant impact on the planning target volume due to the addition of PET imaging information. PET using 18 F-fluorodeoxyglucose (FDG) allows for more precise detection of tumor since it is a functional image based on glucose metabolism rather than structural abnormalities. Biochemical changes often precede any gross anatomical abnormalities, therefore making PET a very powerful imaging modality. FDG PET has been shown to be more sensitive and specific than CT in the staging of NSCLC.Radical radiation therapy is indicated for early stage NSCLC when the patient is medically inoperable primarily due to co-morbidities. In contrast for locally advanced NSCLC, radical radiation is used as part of induction therapy or in the definitive treatment of NSCLC. In order to avoid a geographical miss with precision radiation therapy, the gross tumor volume (GTV) is outlined and a margin around the GTV is added to incorporate microscopic extension of disease, also known as the clinical target volume (CTV). Standard margins of 1.0 to 1.5 cm are used to encompass the gross tumor, microscopic extent and treatment setup uncertainties.There is surprisingly very little data on what constitutes an adequate margin to encompass the microscopic extent around the gross lung tumor. Studies involving conformal radiation therapy and dose escalation in NSCLC have primarily used an empirical margin to define the CTV. A literature review revealed only two studies evaluating the ability of CT to define the gross tumor and its microscopic extension correlated with histopathological measurements [P Giraud et al 2000, R Chan et al 2001]. The two studies have produced conflicting results with recommended margins being from zero mm to 6-8 mm around the GTV. There have been no studies evaluating the ability of PET to define the size of the gross tumor and its microscopic extension.This is a companion study to the two OCOG PET trials in NSCLC. It will evaluate the ability of CT alone versus PET CT to define the gross tumor and its microscopic extension. The methodology will be based on contouring the GTV with imaging modalities of CT and PET CT and correlating the findings with histopathology.This proposed study will add new information on the ability of combined PET CT to determine the microscopic extension of tumor in NSCLC. While no imaging modality can detect microscopic extension, the newer technology of PET CT may give better resolution over CT alone in the detection of tumor. The strength of this proposal is the required correlation with pathological findings. If PET CT is able to accurately determine the extent of disease, this will have major implications on treatment volumes and subsequent targeting for radiation therapy using 3D conformal radiation therapy.
- Conditions
- Non-Small Cell Lung Cancer
- Being tested
- Surgical resection
- Keywords
- Non-small cell lung cancer, Positron emission tomography, Gross tumor volume, Radiation therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
pet ct prior to surgery
| Study group | Role | What they receive |
|---|---|---|
| surgical candidates | Other | surgical candidates who underwent PET CT evaluation Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pathological correlation of PET CT with surgically resected NSCLC
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startOct 2005
- Primary completionJun 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Toronto Sunnybrook Regional Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Cancer Research Network, Ontario Clinical Oncology Group (OCOG)
- Investigators
- Yee C Ung, MD, Principal investigator, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00221169
- Sponsor's protocol ID
- 04-may-00142 OCRN
- Other IDs
- OCRN grant
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 5 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Dahele M, Hwang D, Peressotti C, Sun L, Kusano M, Okhai S, Darling G, Yaffe M, Caldwell C, Mah K, Hornby J, Ehrlich L, Raphael S, Tsao M, Behzadi A, Weigensberg C, Ung YC. Developing a methodology for three-dimensional correlation of PET-CT images and whole-mount histopathology in non-small-cell lung cancer. Curr Oncol. 2008 Oct;15(5):62-9. doi: 10.3747/co.v15i5.349.
PubMed 19008992
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can PET CT Coregistration Imaging Adequately Determine the Gross Tumor Volume and Microscopic Extension in Non-Small Cell Lung Cancer Patients for Radical Radiation Therapy?
- ClinicalTrials.gov ID
- NCT00221169
- Acronym / sponsor ID
- 04-may-00142 OCRN
- Conditions
- Non-Small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Positron emission tomography, Gross tumor volume, Radiation therapy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Toronto Sunnybrook Regional Cancer CentreUniversity, hospital or other
- Collaborators
- Ontario Cancer Research Network, Ontario Clinical Oncology Group (OCOG)
- Study start
- Oct 2005
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 22 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.
Radiation therapy is an important part of the treatment for lung cancer when treatment intent is for cure. Radiation is a local modality of treatment, that is, it only treats the area that the radiation can target. Therefore it is critical to be able to visualize all the areas of tumor involvement. With current imaging tests such as computed tomography scans (CT), the scans may not be sensitive enough to detect all areas of cancer involvement but with newer imaging tests, such as positron emission tomography (PET), the investigators may be able to better target all the tumor that the CT scan may miss. There are two clinical trials being conducted by the Ontario Clinical Oncology Group (OCOG)looking at PET in lung cancer. This proposal is a companion study to the OCOG PET lung trials. In brief, this study will evaluate the ability of CT alone versus combined PET CT imaging to determine the size of the tumor (or gross tumor volume) along with the tiny extensions of cancer cells (or microscopic extension). The gross tumor volume and its extension as determined by CT or PET CT will then be compared to measurements made on the surgically removed tumor. Treatment with radiation therapy must include all the gross tumor and its extension in order to be successful for cure. If the radiation treatment does not treat all the identified tumor then the chance for cure is lost. There have only been two previous reports of the ability of CT to determine the gross tumor volume and its extension. There are no similar reports using PET CT. This study will be the first of its kind to evaluate how accurate PET CT can be in detecting the gross tumor and its microscopic extension using the surgically removed tumor measurements as the gold standard. If PET CT is able to more accurately determine the tumor volume including its microscopic extension, then this will help oncologists to better treat lung cancer using more accurate radiation treatment volumes.
Detailed description
Radiation therapy is an important component in the curative treatment of non-small cell lung cancer. Targeting of the gross tumor has been facilitated by the use of CT simulation allowing for more accurate delineation of the tumor. In addition multi-modality imaging combining functional and anatomical information have allowed for further refinement in the treatment planning process with significant impact on the planning target volume due to the addition of PET imaging information. PET using 18 F-fluorodeoxyglucose (FDG) allows for more precise detection of tumor since it is a functional image based on glucose metabolism rather than structural abnormalities. Biochemical changes often precede any gross anatomical abnormalities, therefore making PET a very powerful imaging modality. FDG PET has been shown to be more sensitive and specific than CT in the staging of NSCLC.Radical radiation therapy is indicated for early stage NSCLC when the patient is medically inoperable primarily due to co-morbidities. In contrast for locally advanced NSCLC, radical radiation is used as part of induction therapy or in the definitive treatment of NSCLC. In order to avoid a geographical miss with precision radiation therapy, the gross tumor volume (GTV) is outlined and a margin around the GTV is added to incorporate microscopic extension of disease, also known as the clinical target volume (CTV). Standard margins of 1.0 to 1.5 cm are used to encompass the gross tumor, microscopic extent and treatment setup uncertainties.There is surprisingly very little data on what constitutes an adequate margin to encompass the microscopic extent around the gross lung tumor. Studies involving conformal radiation therapy and dose escalation in NSCLC have primarily used an empirical margin to define the CTV. A literature review revealed only two studies evaluating the ability of CT to define the gross tumor and its microscopic extension correlated with histopathological measurements [P Giraud et al 2000, R Chan et al 2001]. The two studies have produced conflicting results with recommended margins being from zero mm to 6-8 mm around the GTV. There have been no studies evaluating the ability of PET to define the size of the gross tumor and its microscopic extension.This is a companion study to the two OCOG PET trials in NSCLC. It will evaluate the ability of CT alone versus PET CT to define the gross tumor and its microscopic extension. The methodology will be based on contouring the GTV with imaging modalities of CT and PET CT and correlating the findings with histopathology.This proposed study will add new information on the ability of combined PET CT to determine the microscopic extension of tumor in NSCLC. While no imaging modality can detect microscopic extension, the newer technology of PET CT may give better resolution over CT alone in the detection of tumor. The strength of this proposal is the required correlation with pathological findings. If PET CT is able to accurately determine the extent of disease, this will have major implications on treatment volumes and subsequent targeting for radiation therapy using 3D conformal radiation therapy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| surgical candidates | Other | Procedure: Surgical resectionsurgical candidates who underwent PET CT evaluation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgically resectable non-small cell lung cancer
- Companion clinical trial to OCOG PET Lung trials
Key exclusion criteria (2 listed)
- Unresectable non-small cell lung cancer
- Unable to undergo PET CT evaluation
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 |
|---|---|---|
| Surgical resectionpet ct prior to surgery | Procedure or surgery | surgical candidates |
Primary outcome
Clinical pathological correlation of PET CT with surgically resected NSCLC
Time frame: 2 years
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 5 Feb 2009.
- Results publication: PubMed 19008992Dahele M, Hwang D, Peressotti C, Sun L, Kusano M, Okhai S, Darling G, Yaffe M, Caldwell C, Mah K, Hornby J, Ehrlich L, Raphael S, Tsao M, Behzadi A, Weigensberg C, Ung YC. Developing a methodology for three-dimensional correlation of PET-CT images and whole-mount histopathology in non-small-cell lung cancer. Curr Oncol. 2008 Oct;15(5):62-9. doi: 10.3747/co.v15i5.349.
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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.
Yee C Ung, MD principal investigator
Toronto Sunnybrook Regional Cancer Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Surgical resection in people with Non-Small Cell Lung Cancer, run by Toronto Sunnybrook Regional Cancer Centre at 2 sites 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 2 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 5 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Clinical pathological correlation of PET CT with surgically resected NSCLC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00221169, which also lists 1 linked publication.
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 5 Feb 2009.