Low-Dose CT - Stage I Testicular Cancer

Testicular Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03142802
• Other study ID #: 05-0436-CE
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 16, 2005
• Est. completion date: September 2025

Study information

• Verified date: December 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 251
• Est. completion date: September 2025
• Est. primary completion date: October 14, 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Testicular Cancer
• Testicular Neoplasms

Intervention

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: 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

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time on surveillance	Amount of time patient is on surveillance before detection of relapse.	6 years
Secondary	Amount of false positive rate of LDCTs		6 years
Secondary	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
Secondary	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
Secondary	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
Secondary	Proportion of disease-free survival	To document proportion of disease-free survival	6 years
Secondary	Proportion of overall survival	To document proportion of overall survival	6 years
Secondary	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