Low-Dose CT - Stage I Testicular Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Testicular Cancer

Intervention / Treatment
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* Diagnostic Test: Low-dose computed tomography (LDCT)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Patients diagnosed with testicular germ cell cancer will undergo both standard and low dose CT scan of the abdomen and pelvis.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with testicular germ cell cancer<br>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. | Diagnostic Test: Low-dose computed tomography (LDCT)<br>* 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: Normal LDCT: - Patient continues on the study (i.e. continued surveillance) 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 Elevated serum tumour markers or other evidence of metastatic disease: Patient goes off study<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in size of the retroperitoneal lymph node mass | The difference in size of lymph node mass at the time of relapse between low dose CT and conventional CT. This is to evaluate the effectiveness of using low-dose CT in patients undergoing surveillance. | 9 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on surveillance | Amount of time patient is on surveillance before detection of relapse. | 6 years | 
| Amount of false positive rate of LDCTs |  | 6 years | 
| Proportion of patients unsuitable for LDCT surveillance | Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality | 6 years | 
| Proportion of patients who have to discontinue LDCT surveillance | Gather information on proportion of patients who had to discontinue LDCT surveillance due to poor image quality. | 6 years | 
| Amount of prospective identification of first modality to detect relapse | To prospectively identify the first modality to detect relapse (patient symptoms, clinical examination, tumour marker, imaging) | 6 years | 
| Proportion of disease-free survival | To document proportion of disease-free survival | 6 years | 
| Proportion of overall survival | To document proportion of overall survival | 6 years | 
| Amount of prospective documentation of treatment for testicular germ cell cancer relapse | To prospectively document the treatment types for patients who have relapsed. | 6 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Testicular cancer, low-dose CT, CT scan