NCT03142802

Low-Dose CT - Stage I Testicular Cancer

Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: University Health Network, Toronto · Academic / Other
• Sex: Male
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

Patients with primary germ cell cancer of the testicles confined to the testis can avoid adjuvant treatment by entering a surveillance protocol. In the surveillance protocol, patients are followed for up to ten years with serial computed tomography scans to detect recurrence. Multiple CT scans expose patients to a significant amount of radiation, which may be associated with an increased risk of secondary malignancies. This study hypothesizes that low dose CT scans are as effective as standard dose CT scans in detecting disease recurrence in this setting and will significantly reduce radiation exposure in this group of patients.

Conditions

• Testicular Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Low-dose computed tomography (LDCT)	In phase A of the study, patients will undergo conventional CT along with low dose CT. If patients have a normal conventional CT and a satisfactory low dose CT, they will move onto Phase B of the study in which they will undergo surveillance using low-dose CT. Three outcomes are possible with low-dose CT surveillance: 1. Normal LDCT: \- Patient continues on the study (i.e. continued surveillance) 2. Suspicious LDCT: \- Will undergo conventional CT and if results are normal, patient will continue on study. If conventional CT is abnormal, they will be taken off study 3. Elevated serum tumour markers or other evidence of metastatic disease: * Patient goes off study

Timeline

• Start date: 2005-09-16
• Primary completion: 2011-10-14
• Completion: 2028-09-01
• First posted: 2017-05-05
• Last updated: 2025-02-10

Locations

1 site across 1 country: Canada