Low-Dose CT - Stage I Testicular Cancer

University Health Network, Toronto

Status: Active, not recruiting

Conditions: Testicular Cancer

Treatments: Diagnostic Test: Low-dose computed tomography (LDCT)

Study type: Interventional

Funder types: Other

Identifiers

NCT03142802

05-0436-CE

Details and patient eligibility

About

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.

Enrollment: 251 patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Phase A:
• Newly diagnosed testicular germ cell testicular cancer (GCT) with no clinical or tumour marker evidence of metastases
• Stage I disease according to UICC stage groupings and currently on surveillance (in Year 1 of non-seminoma surveillance or year 1 or 2 of seminoma surveillance)
• ECOG performance status 0 or 1
• Phase B:
• Stage I disease according to UICC stage Groupings
• Initial Low dose CT considered by study radiologist to be of sufficient quality to allow surveillance using LDCT protocol

Exclusion criteria

• any medical conditions that render the patient ineligible to undergo the protocol or procedure

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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251 participants in 1 patient group

Patients with testicular germ cell cancer

Experimental group

Description:

Patients with testicular germ cell cancer who have either been newly diagnosed, or have stage I cancer already on surveillance program will undergo conventional and low dose CT. Based on the imaging, they may undergo a surveillance program using low-dose CT.

Treatment:

Diagnostic Test: Low-dose computed tomography (LDCT)