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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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 groups in NCT00221169
Study groupRoleWhat they receive
surgical candidatesOthersurgical 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.

  1. 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.

  1. First posted22 Sep 2005 (estimated)
  2. Study startOct 2005
  3. Primary completionJun 2008
  4. Study completionJan 2009

Resources

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)
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

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.

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