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Active, not recruitingNCT03142802Updated Jun 23, 2026

Low-Dose CT - Stage I Testicular Cancer

An interventional study of Low-dose computed tomography (LDCT) in Testicular Cancer, sponsored by University Health Network, Toronto. Active, not recruiting at 1 site in Canada. Open to male participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by University Health Network, Toronto · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 11 years 7 months after the study started (first participant enrolled Sep 2005, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
251
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
Male
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Study 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.

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Conditions studied

  • Testicular Cancer

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Keywords

  • Testicular cancer
  • low-dose CT
  • CT scan
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In context

Testicular Neoplasms

189 studies on the registry are indexed under Testicular Neoplasms; 53 are open to participants now.

This study's enrollment of 251 is above the median of 59 across 122 interventional studies indexed under Testicular Neoplasms.

Browse Testicular Neoplasms studies →

Lead sponsor

University Health Network, Toronto is the lead sponsor of 1,411 studies on the registry; 292 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • any medical conditions that render the patient ineligible to undergo the protocol or procedure
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
251 participants (actual)

Study arms

  • 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)

Interventions

  • Diagnostic testLow-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: 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

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What researchers measure

Primary outcomes

  1. 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

  1. Time on surveillance

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

    Time frame: 6 years

  2. Amount of false positive rate of LDCTs

    Time frame: 6 years

  3. 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

  4. 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

  5. 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

  6. Proportion of disease-free survival

    To document proportion of disease-free survival

    Time frame: 6 years

  7. Proportion of overall survival

    To document proportion of overall survival

    Time frame: 6 years

  8. Amount of prospective documentation of treatment for testicular germ cell cancer relapse

    To prospectively document the treatment types for patients who have relapsed.

    Time frame: 6 Years

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Study locations

1 site
  • University Health Network, Princess Margaret Hospital
    Toronto, Ontario M5G 2M9, Canada
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References and documents

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. PubMed 31277780 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03142802
Lead sponsor
University Health Network, Toronto
Responsible party
Sponsor
First posted
May 5, 2017
Start date
Sep 16, 2005
Primary completion
Oct 14, 2011
Completion
Sep 2028 (estimated)
Last update
Jun 23, 2026

Study contacts

Peter Chung
principal investigator · The Princess Margaret Cancer Foundation

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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