Clinical trial · Interventional
Preoperative Assessment of Mesorectal Lymph Nodes by Dual Energy CT. PUMK-DECT
- 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)
Endpoints subproject 1: To develop a reproducible method for the detection of lymph nodes by DECT in operation specimens from rectal resection for cancer. sub project 2: Primary endpoint: To evaluate the sensitivity and specificity for malignant lymph nodes in vitro RC specimens compared with histopathology. Secondary endpoint: To assess DECT as imaging tool for the diagnosis of malignant lymph nodes at RC. Histopathology will be used as reference.Subproject 3: Primary endpoint: To compare the sensitivity, specificity, positive- and negative predictive values, accuracy of DECT and standard MRI. Secondary: To evaluate the value of the gold standard for the use of imaging methods for the description of the lymph node, validated by histopathology. Secondary: to determine the value of tumor diagnostics using DECT.subproject 4: To assess the value of DECT as imaging tool for diagnosing response to chemo radiotherapy of malignant lymph nodes.
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 |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dual energy computed tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- dual energy ct
- interventionNames
- Device: Dual energy computed tomography
Primary outcomes (4)
- measure
- the detection of lymph nodes by DECT in specimens from rectal resection for cancer.
- timeFrame
- 6 months
- description
- Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.
- measure
- sensitivity and specificity for the detection of malignant lymph nodes in vitro RC specimens compared with histopathology
- timeFrame
- 6 months
- description
- Measurments will be done in Hounsfield units, effective z-value and iodine, water and gadolinium concentrations.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: \- All patients with an endoscopic suspected rectal cancer. Exclusion Criteria: * Chronic kidney failure * pregnancy * rectal cancer recurrence * known contrast allergies
References
Publications (0)
Data not yet available