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NCT Number: NCT03142802

Low-Dose CT - 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Testicular Cancer Endocrine Gland Neoplasms Endocrine System Diseases Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Gonadal Disorders Male Urogenital Diseases Neoplasms Neoplasms by Site Testicular Diseases Testicular Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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:

  • 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 outcomes

  1. Difference in size of the retroperitoneal lymph node mass

    Time frame: 9 years

    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 outcomes

  1. Time on surveillance

    Time frame: 6 years

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

  2. Amount of false positive rate of LDCTs

    Time frame: 6 years

  3. Proportion of patients unsuitable for LDCT surveillance

    Time frame: 6 years

    Gather information on proportion of patients who were unsuitable for LDCT surveillance due to poor image quality

  4. Proportion of patients who have to discontinue LDCT surveillance

    Time frame: 6 years

    Gather information on proportion of patients who had to discontinue LDCT surveillance due to poor image quality.

  5. Amount of prospective identification of first modality to detect relapse

    Time frame: 6 years

    To prospectively identify the first modality to detect relapse (patient symptoms, clinical examination, tumour marker, imaging)

  6. Proportion of disease-free survival

    Time frame: 6 years

    To document proportion of disease-free survival

  7. Proportion of overall survival

    Time frame: 6 years

    To document proportion of overall survival

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

    Time frame: 6 Years

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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2028
First posted
May 5, 2017
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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