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Low-Dose CT - Stage I Testicular Cancer

Primary Purpose

Testicular Cancer

Status
Active
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Low-dose computed tomography (LDCT)
Sponsored by
University Health Network, Toronto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Testicular Cancer focused on measuring Testicular cancer, low-dose CT, CT scan

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • University Health Network, Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with testicular germ cell cancer

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Time on surveillance
Amount of time patient is on surveillance before detection of relapse.
Amount of false positive rate of LDCTs
Proportion of patients unsuitable for LDCT surveillance
Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality
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.
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)
Proportion of disease-free survival
To document proportion of disease-free survival
Proportion of overall survival
To document proportion of overall survival
Amount of prospective documentation of treatment for testicular germ cell cancer relapse
To prospectively document the treatment types for patients who have relapsed.

Full Information

First Posted
April 27, 2017
Last Updated
May 7, 2023
Sponsor
University Health Network, Toronto
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1. Study Identification

Unique Protocol Identification Number
NCT03142802
Brief Title
Low-Dose CT - Stage I Testicular Cancer
Official Title
Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 16, 2005 (Actual)
Primary Completion Date
October 14, 2011 (Actual)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Testicular Cancer
Keywords
Testicular cancer, low-dose CT, CT scan

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with testicular germ cell cancer
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Low-dose computed tomography (LDCT)
Intervention Description
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
Primary Outcome Measure Information:
Title
Difference in size of the retroperitoneal lymph node mass
Description
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 Outcome Measure Information:
Title
Time on surveillance
Description
Amount of time patient is on surveillance before detection of relapse.
Time Frame
6 years
Title
Amount of false positive rate of LDCTs
Time Frame
6 years
Title
Proportion of patients unsuitable for LDCT surveillance
Description
Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality
Time Frame
6 years
Title
Proportion of patients who have to discontinue LDCT surveillance
Description
Gather information on proportion of patients who had to discontinue LDCT surveillance due to poor image quality.
Time Frame
6 years
Title
Amount of prospective identification of first modality to detect relapse
Description
To prospectively identify the first modality to detect relapse (patient symptoms, clinical examination, tumour marker, imaging)
Time Frame
6 years
Title
Proportion of disease-free survival
Description
To document proportion of disease-free survival
Time Frame
6 years
Title
Proportion of overall survival
Description
To document proportion of overall survival
Time Frame
6 years
Title
Amount of prospective documentation of treatment for testicular germ cell cancer relapse
Description
To prospectively document the treatment types for patients who have relapsed.
Time Frame
6 Years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Chung
Organizational Affiliation
The Princess Margaret Cancer Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network, Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31277780
Citation
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.
Results Reference
derived

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Low-Dose CT - Stage I Testicular Cancer

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