Low-Dose CT - Stage I Testicular Cancer

NCT03142802 | Active Not Recruiting

• 1 other identifier: 05-0436-CE
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

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.

Conditions

Testicular Cancer

Keywords

Testicular cancer; low-dose CT; CT scan

Outcome Measures

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.

  9 years

Secondary Outcomes (8)

• Time on surveillance

  6 years

• Amount of false positive rate of LDCTs

  6 years

• Proportion of patients unsuitable for LDCT surveillance

  6 years

• Proportion of patients who have to discontinue LDCT surveillance

  6 years

• Amount of prospective identification of first modality to detect relapse

  6 years

Study Arms (1)

Patients with testicular germ cell cancer

EXPERIMENTAL

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

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: 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

Patients with testicular germ cell cancer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network, Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• 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.

  PMID: 31277780 DERIVED

MeSH Terms

Conditions

Testicular Neoplasms

Interventions

Tomography, X-Ray Computed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Peter Chung

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients diagnosed with testicular germ cell cancer will undergo both standard and low dose CT scan of the abdomen and pelvis.

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 5, 2017
• Study Start: September 16, 2005
• Primary Completion: October 14, 2011
• Study Completion (Estimated): September 1, 2028
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

CA (1)