Low Dose Chest Computed Tomography (CT) Screening

Hodgkin's Lymphoma Clinical Trial

Official title:

Low-Dose Chest CT for Lung Cancer Screening in Survivors of Hodgkin's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180010
• Other study ID #: UHN REB 08-0294-CE
• Status: Completed
• Phase: N/A
• First received: August 10, 2010
• Last updated: December 28, 2016
• Start date: August 2010
• Est. completion date: September 2015

Study information

• Verified date: December 2016
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Canada	University Health Network, Princess Margaret Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lung cancer detection rate using chest CT screening in patients at increased risk of lung cancer after Hodgkin's disease therapy.		5 years	No
Primary	False-positive rates of using chest CT for lung cancer screening in this population.		5 years	No
Secondary	The stage distribution, clinical characteristics and pathologic features of the detected lung cancer		5 years	No
Secondary	The treatment and treatment outcome of lung cancer after Hodgkin's disease in a cohort of patients undergoing routine chest CT screening		5 years	No