Low-Dose CT - Stage I Testicular Cancer

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

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 Overview

• Status: Active, not recruiting
• Conditions: Testicular Cancer
• Intervention / Treatment: Diagnostic test: Low-dose computed tomography (LDCT)

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network, Princess Margaret Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Patients with testicular germ cell cancer; 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); 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Investigators: Principal Investigator: Peter Chung, The Princess Margaret Cancer Foundation

Publications and helpful links

General Publications

• Chung P, O'Malley ME, Jewett MAS, Bedard PL, Panzarella T, Sturgeon J, Moore MJ, Hamilton R, Hansen AR, Anson-Cartwright L, Gospodarowicz M, Warde P. Detection of Relapse by Low-dose Computed Tomography During Surveillance in Stage I Testicular Germ Cell Tumours. Eur Urol Oncol. 2019 Jul;2(4):437-442. doi: 10.1016/j.euo.2018.08.031. Epub 2018 Oct 2.

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2005
• Primary Completion (Actual): October 14, 2011
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: May 4, 2017
• First Posted (Actual): May 5, 2017

Study Record Updates

• Last Update Posted (Estimated): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: CT scan; low-dose CT; Testicular cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Endocrine System Diseases; Gonadal Disorders; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Testicular Neoplasms
• Other Study ID Numbers: 05-0436-CE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No