Evaluating new methods for classifying lymph nodes in cancer patients
Comparison of the LN-RADS, RECIST 1.1 and Node-RADS Classification in the Assessment of Lymph Nodes in MRI and CT in Relation to Histopathological Results - a Prospective, Randomised Study
This study is testing a new way to classify lymph nodes in cancer patients to see if it helps doctors make better treatment decisions.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Copernicus Memorial Hospital Academic / other |
| Locations | 6 sites (Krakow and 5 other locations) |
| Trial ID | NCT06527027 on ClinicalTrials.gov |
What this trial studies
This project aims to assess the effectiveness of the LN-RADS classification system for lymph nodes in comparison to the established RECIST 1.1 and Node-RADS methods using CT and MRI imaging. The study focuses on patients diagnosed with or suspected of having cancer who are undergoing lymph node biopsies or surgeries. By improving the accuracy of lymph node assessment, the study seeks to enhance diagnostic capabilities and treatment planning in oncology. The research will involve analyzing imaging results to determine the presence of neoplastic changes in lymph nodes.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with or suspected of having cancer who require lymph node evaluation through imaging.
Not a fit: Patients with non-diagnostic imaging results or inconclusive histopathological findings may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of lymph node metastases, improving treatment outcomes for cancer patients.
How similar studies have performed: Other studies have shown promise in improving lymph node classification methods, but the LN-RADS approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * diagnosed or suspected cancer, * planned lymph node biopsy or lymphadenectomy, * planned or performed CT/MRI covering an area of the body with lymph nodes, - verified histopathologically or cytologically, * informed consent to participate in the study. Exclusion Criteria: * non-diagnostic CT/MRI images of lymph nodes due to reasons such as movement artifacts, artifacts from metal elements and any other factors that do not allow for proper assessment of the nodes, * inconclusive histopathological or cytological results, which do not allow the nodes to be classified into one of two groups - benign or malignant.
Where this trial is running
Krakow and 5 other locations
- Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute — Krakow, Poland (Active_not_recruiting)
- Copernicus Memorial Hospital — Lodz, Poland (Recruiting)
- Independent Public Healthcare Centre (SPZOZ) , University Clinical Hospital No. 2 of the Medical University of Łódź — Lodz, Poland (Active_not_recruiting)
- Doradztwo i Zarządzanie w Opiece Zdrowotnej A.K. Sp.z o.o — Warsaw, Poland (Active_not_recruiting)
- Maria Skłodowska-Curie National Research Institute of Oncology - National Research Institute — Warsaw, Poland (Active_not_recruiting)
- Professor Orłowski Hospital in Warsaw , Independent Public Healthcare Centre — Warsaw, Poland (Active_not_recruiting)
Study contacts
- Principal investigator: Cezary Chudobiński, PhD — Copernicus Memoriał Hospital
- Study coordinator: Cezary Chudobiński, PhD
- Email: cezary.chudobinski@wp.pl
- Phone: +4842 689 58 99
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.