Clinical trial · Interventional
Low-Dose CT - Stage I Testicular Cancer
Phase II Study of Effectiveness of Using Low-dose CT in Patient Undergoing Surveillance for Clinical Stage I Testicular Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Testicular Cancer | Malignant Testicular Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-dose computed tomography (LDCT) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients with testicular germ cell cancer
- description
- 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.
- interventionNames
- Diagnostic Test: Low-dose computed tomography (LDCT)
Primary outcomes (1)
- measure
- Difference in size of the retroperitoneal lymph node mass
- timeFrame
- 9 years
- description
- 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 (8)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDChung 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