Low-Dose CT - Stage I Testicular Cancer

N/AActive Not RecruitingNCT03142802

University Health Network, Toronto251 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

251

Conditions

Testicular Cancer

Interventions

Low-dose computed tomography (LDCT)DIAGNOSTIC_TEST

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

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.

Time frame: 9 years

Secondary Outcomes

Time on surveillance

Amount of time patient is on surveillance before detection of relapse.

Time frame: 6 years

Amount of false positive rate of LDCTs

Time frame: 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

Time frame: 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.

Time frame: 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)

Time frame: 6 years

Proportion of disease-free survival

To document proportion of disease-free survival

Time frame: 6 years

Proportion of overall survival

Data from ClinicalTrials.gov

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