NCT00221169

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P75+ for early_phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Oct 2005

Typical duration for early_phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Study Start

First participant enrolled

October 1, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

February 5, 2009

Status Verified

February 1, 2009

Enrollment Period

2.7 years

First QC Date

September 13, 2005

Last Update Submit

February 4, 2009

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-small cell lung cancerPositron emission tomographyGross tumor volumeRadiation therapy

Outcome Measures

Primary Outcomes (1)

  • Clinical pathological correlation of PET CT with surgically resected NSCLC

    2 years

Study Arms (1)

surgical candidates

OTHER

surgical candidates who underwent PET CT evaluation

Procedure: Surgical resection

Interventions

Surgical resectionPROCEDURE

pet ct prior to surgery

surgical candidates

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Surgically resectable non-small cell lung cancer
  • Companion clinical trial to OCOG PET Lung trials

You may not qualify if:

  • Unresectable non-small cell lung cancer
  • Unable to undergo PET CT evaluation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Toronto Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (1)

  • 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.

    PMID: 19008992RESULT

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Yee C Ung, MD

    Toronto Sunnybrook Regional Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

October 1, 2005

Primary Completion

June 1, 2008

Study Completion

January 1, 2009

Last Updated

February 5, 2009

Record last verified: 2009-02

Locations

CA(2)