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Low Dose Chest Computed Tomography (CT) Screening

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01180010
First received: August 10, 2010
Last updated: December 19, 2012
Last verified: December 2012
History of Changes
  Purpose

This research study is being done because patients with a history of chest radiation treatment for Hodgkin's disease have been shown to be at increased risk for developing lung cancer a number of years out from treatment. The risk appears to be further increased among patients with a smoking history. In this study, the CT scans will be read and interpreted by the study radiologist, and the results recorded in a consistent manner. Depending on the findings of the initial CT scan, we will then either repeat the scan in 1 year, or if indicated, send you for further scans or a biopsy. The information collected in this study will help researchers and clinicians in providing more concrete recommendations and screening guidelines for future survivors of Hodgkin's disease who have had similar exposures to radiation and/or chemotherapy and smoking.


Condition Intervention
Hodgkin's Lymphoma
 Procedure: Low Dose CT

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Low-Dose Chest CT for Lung Cancer Screening in Survivors of Hodgkin's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Lung cancer detection rate using chest CT screening in patients at increased risk of lung cancer after Hodgkin's disease therapy. [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • False-positive rates of using chest CT for lung cancer screening in this population. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The stage distribution, clinical characteristics and pathologic features of the detected lung cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • The treatment and treatment outcome of lung cancer after Hodgkin's disease in a cohort of patients undergoing routine chest CT screening [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 31
Study Start Date: August 2010
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Low Dose CT
    A chest CT uses special radiographic equipment using x-rays to capture images of the chest, and with the aid of a computer, processes the images to create cross-sectional pictures or "slices" of the areas of interest. The images can then be printed out or examined on a monitor. The CT scanner is a large unit with a hole running directly through its center, giving the appearance of a doughnut. During the scanning, patients will lie flat on their back on a table, and they are periodically asked to hold their breath. The table will first move through the scanner to determine the correct starting position. The rest of the scans are made as the table moves more slowly through the cavity in the scanner.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated for Hodgkin's Lymphoma

Criteria

Inclusion Criteria:

  1. 5 years or longer from initial Hodgkin's disease diagnosis
  2. Current age 18 or older
  3. Received mediastinal irradiation and/or alkylating-agent based chemotherapy
  4. Smoking history of 10-pack years or more, or current smoker

Exclusion Criteria:

  1. Patients with a history of lung cancer
  2. Patients currently receiving treatment for another cancer diagnosis (patients with another cancer, but currently disease-free and not receiving treatment are eligible)
  3. Patients with known diagnosis of any metastatic cancer
  4. Pregnant women. Female patients must: be at least one year post-menopausal, have had a hysterectomy, or have a serum pregnancy test to confirm that they are not pregnant. These measures must be taken in order to avoid doing a CT scan of a pregnant woman.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180010

Locations
Canada, Ontario
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
Investigators
Principal Investigator: David Hodgson, MD University Health Network, Princess Margaret Hospital
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01180010     History of Changes
Other Study ID Numbers: UHN REB 08-0294-CE
Study First Received: August 10, 2010
Last Updated: December 19, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Hodgkin's Lymphoma
Lung Cancer
Lung Nodule
CT scan

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013