Low-Dose CT - Stage I Testicular Cancer
- Conditions
- Testicular Cancer
- Interventions
- Diagnostic Test: Low-dose computed tomography (LDCT)
- Registration Number
- NCT03142802
- Lead Sponsor
- University Health Network, Toronto
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Male
- Target Recruitment
- 251
- 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
- any medical conditions that render the patient ineligible to undergo the protocol or procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Patients with testicular germ cell cancer Low-dose computed tomography (LDCT) 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.
- Primary Outcome Measures
Name Time Method Difference in size of the retroperitoneal lymph node mass 9 years 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.
- Secondary Outcome Measures
Name Time Method Amount of false positive rate of LDCTs 6 years Amount of prospective identification of first modality to detect relapse 6 years To prospectively identify the first modality to detect relapse (patient symptoms, clinical examination, tumour marker, imaging)
Amount of prospective documentation of treatment for testicular germ cell cancer relapse 6 Years To prospectively document the treatment types for patients who have relapsed.
Time on surveillance 6 years Amount of time patient is on surveillance before detection of relapse.
Proportion of patients who have to discontinue LDCT surveillance 6 years Gather information on proportion of patients who had to discontinue LDCT surveillance due to poor image quality.
Proportion of disease-free survival 6 years To document proportion of disease-free survival
Proportion of patients unsuitable for LDCT surveillance 6 years Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality
Proportion of overall survival 6 years To document proportion of overall survival
Trial Locations
- Locations (1)
University Health Network, Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada