Low-Dose CT Scans for Testicular Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

251 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on using low-dose CT scans for monitoring testicular cancer.

What data supports the effectiveness of the treatment Low-dose computed tomography (LDCT) for testicular cancer?

Research shows that low-dose CT scans can effectively monitor patients with early-stage testicular cancer, providing similar image quality to standard-dose scans while reducing radiation exposure. ^{1 2 3 4 5}

Is low-dose CT scanning safe for humans?

Low-dose CT scans are generally considered safer than standard-dose CT scans because they expose patients to less radiation, which may reduce the risk of developing cancer from the radiation exposure. ^{1 2 3 4 6}

How does low-dose CT scanning differ from other treatments for testicular cancer?

Low-dose CT scanning is unique because it uses a lower amount of radiation compared to standard CT scans, which helps reduce the risk of radiation exposure while still effectively monitoring for cancer recurrence. ^{1 7 8 9 10}

Research Team

Peter Chung, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Eligibility Criteria

This trial is for individuals with Stage I testicular cancer who are in their first year of surveillance for non-seminoma or within the first two years for seminoma. They must have a good performance status, meaning they're fully active or restricted in physically strenuous activity but can do light work.

Inclusion Criteria

I am in the first year of surveillance for stage I non-seminoma or in the first or second year for seminoma.

I have newly diagnosed testicular cancer with no signs it has spread.

I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

I do not have any health issues that would prevent me from following the study's procedures.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surveillance

Participants undergo surveillance with serial low-dose CT scans to detect recurrence

10 years

Regular visits for CT scans

Follow-up

Participants are monitored for safety and effectiveness after surveillance

6 years

Treatment Details

Interventions

• Low-dose computed tomography (LDCT)

Trial Overview The study is testing if low-dose computed tomography (LDCT) scans are as effective as standard CT scans at spotting cancer recurrence while reducing radiation exposure over up to ten years of patient follow-up.

Participant Groups

Group I: Patients with testicular germ cell cancer Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Findings from Research

In a study of 121 patients who underwent low-dose computed tomography (LDCT) screening for lung cancer, the overall adherence rate to follow-up scans was only 59.1%, indicating a need for improved compliance with screening guidelines.

Patients with more concerning findings (Lung-RADS score 2) were 2.43 times more likely to adhere to follow-up scans compared to those with less concerning findings (Lung-RADS score 1), while African American patients showed lower odds of adherence, highlighting potential socioeconomic disparities in lung cancer screening compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. Mortman, KD., Devlin, J., Giang, B., et al.[2023]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Detection of Relapse by Low-dose Computed Tomography During Surveillance in Stage I Testicular Germ Cell Tumours. [2020]

2. Germany pubmed.ncbi.nlm.nih.gov

Comparison of low dose with standard dose abdominal/pelvic multidetector CT in patients with stage 1 testicular cancer under surveillance. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Feasibility of low-dose CT with model-based iterative image reconstruction in follow-up of patients with testicular cancer. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Automated tube potential selection for standard chest and abdominal CT in follow-up patients with testicular cancer: comparison with fixed tube potential. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Retroperitoneal imaging with third and fourth generation computed axial tomography in clinical stage I nonseminomatous germ cell tumors. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Frequency of computed tomography examinations in the follow-up care of testicular cancer patients - an evaluation of patterns of care in Germany. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Baseline findings of a randomized feasibility trial of lung cancer screening with spiral CT scan vs chest radiograph: the Lung Screening Study of the National Cancer Institute. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

Low-dose CT: a useful and accessible tool for the early diagnosis of lung cancer in selected populations. [2007]

9. United States pubmed.ncbi.nlm.nih.gov

Domain-adaptive denoising network for low-dose CT via noise estimation and transfer learning. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. [2023]