Low Dose Chest Computed Tomography (CT) Screening

• ClinicalTrials.gov Identifier: NCT01180010
• Recruitment Status: Completed
• First Posted: August 11, 2010
• Last Update Posted: December 29, 2016
• Sponsor: University Health Network, Toronto
• Collaborator: Princess Margaret Hospital, Canada
• Information provided by (Responsible Party): University Health Network, Toronto

Study Description

Brief Summary:

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 or disease	Intervention/treatment
Hodgkin's Lymphoma	Procedure: Low Dose CT

Study Design

• Study Type: Observational
• Actual Enrollment: 31 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Low-Dose Chest CT for Lung Cancer Screening in Survivors of Hodgkin's Disease
• Study Start Date: August 2010
• Actual Primary Completion Date: September 2015
• Actual Study Completion Date: September 2015

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

1. 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 ]
2. False-positive rates of using chest CT for lung cancer screening in this population. [ Time Frame: 5 years ]

Secondary Outcome Measures :

1. The stage distribution, clinical characteristics and pathologic features of the detected lung cancer [ Time Frame: 5 years ]
2. 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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

• Responsible Party: University Health Network, Toronto
• ClinicalTrials.gov Identifier: NCT01180010
• Other Study ID Numbers: UHN REB 08-0294-CE
• First Posted: August 11, 2010
• Last Update Posted: December 29, 2016
• Last Verified: December 2016

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