Low-Dose CT Scans for Testicular Cancer

Age: 18+

Sex: Male

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Metastases, Poor ECOG status, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial seeks to determine if low-dose CT scans (low-dose computed tomography) can effectively monitor testicular cancer while minimizing radiation exposure. The trial aims to assist those with testicular germ cell cancer by using low-dose CT scans to detect cancer recurrence, potentially reducing the risk of developing other cancers later. It suits individuals recently diagnosed with testicular germ cell cancer who are currently monitored without signs of disease spread. Participants will undergo both conventional and low-dose CT scans, with the goal of transitioning to low-dose scans if proven effective. This approach aims to provide a safer long-term monitoring option for patients. As an unphased trial, this study offers a unique opportunity to contribute to safer cancer monitoring methods.

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 prior data suggests that low-dose CT scans are safe for patients with testicular germ cell cancer?

Research shows that low-dose computed tomography (LDCT) safely monitors testicular cancer. Previous studies have found that LDCT uses less radiation than standard CT scans, which is important because less radiation reduces the risk of developing other cancers in the future.

Research strongly supports the safety of LDCT. Studies indicate that using LDCT to monitor stage I germ cell tumors, such as testicular cancer, effectively detects relapses without compromising patient safety. Patients undergoing LDCT monitoring also experience fewer side effects from radiation.

In summary, LDCT is considered safe and well-tolerated for patients. It provides an effective way to monitor testicular cancer while minimizing potential radiation risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using low-dose CT scans for testicular cancer because these scans aim to reduce radiation exposure while still effectively monitoring the condition. Traditional CT scans, while effective, expose patients to higher doses of radiation, which can be a concern, especially for young patients who may require multiple scans over time. Low-dose CT scans offer a promising alternative by delivering the necessary imaging with significantly less radiation, potentially reducing long-term health risks. This approach could make cancer surveillance safer while still providing the detailed imagery needed to track the disease.

What evidence suggests that low-dose CT scans are effective for detecting testicular cancer recurrence?

Studies have shown that low-dose CT scans effectively monitor early-stage testicular cancer. Research indicates these scans can detect cancer recurrence in the abdomen and pelvis with image quality comparable to regular-dose CT scans. This method uses less radiation, potentially reducing the risk of developing other cancers later. In this trial, patients with testicular germ cell cancer will undergo both conventional and low-dose CT scans. For those under surveillance, low-dose CT provides a safer option without compromising the ability to detect cancer recurrence. Evidence supports its success in identifying relapses. ^{1 2 4 6 7}

Who Is on the Research Team?

Peter Chung, MD

Principal Investigator

The Princess Margaret Cancer Foundation

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31277780/

Detection of Relapse by Low-dose Computed Tomography ... LDCT can be safely adopted and will decrease overall radiation exposure in stage I germ cell tumour surveillance. Patient summary: We studied the use of low- ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03142802

Study Details | Low-Dose CT - Stage I Testicular Cancer 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.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2588931118301500

Detection of Relapse by Low-dose Computed Tomography ... We studied the use of low-dose computed tomography scans for detecting testicular cancer recurrence in lymph nodes of the abdomen and pelvis and found that they ...

4. withpower.com withpower.com/trial/phase-testicular-neoplasms-8-2005-9f174

Low-Dose CT Scans 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 ...

5. ascopubs.org ascopubs.org/doi/10.1200/EDBK-25-472654

Key Updates in Testicular Cancer: Optimizing Survivorship ... TCSs have a 1.4-2.4-fold excess risk of developing a non–germ cell SMN after treatment with CBCT and/or radiotherapy, while surgery alone is ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2666168322000635

Safety of Minimizing Intensity of Follow-up on Active ... These results support that our current lower-intensity active surveillance schedules are safe for managing CSI GCT.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7614664/

Imaging Modality and Frequency in Surveillance of Stage I ... Survival in stage I seminoma is almost 100%. Computed tomography (CT) surveillance is an international standard of care, avoiding adjuvant ...