Rectal Cancer
Conditions
Brief summary
Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.
Detailed description
Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. Nanoparticles are injected close to the rectal cancer and migrate to adjacent lymph nodes.The time-varying magnetic field will influence the nano particles in the lymph node enhancing diagnosis of affected lymph nodes. The aim is to improve diagnosis of mesolectal lymph nodes and compare the results of magnetomotoric ultrasound with MRI and final histopathology.
Interventions
DIAGNOSTIC_TESTMagnetomotoric ultrasound
Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.
Sponsors
Region Skane
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Included patients will undergo magnetomotoric ultrasound in addition to conventional MRI. The results of MRI examination and magnetomotoric ultrasound will be compared with final histopathology.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Rectal cancer * Scheduled for total mesorectal surgery * Informed consent
Exclusion criteria
* Not able to give informed consent * Synchronus colorectal cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology | Approximately 1 hour after MMUS | Evaluation of the accuracy of MMUS in detecting lymph node metastases in rectal cancer. The results of the MMUS (malignant or benign lymph nodes) will be compared with final histopathology. The accuracy will be expressed in sensitivity (%), specificity (%) and overall accuracy (% correctly staged lymph nodes with MMUS) |
| Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI | Approximately 1 hour after MMUS | Evaluation of the accuracy of MMUS in detecting lymph node metastases in rectal cancer in comparison to standard staging (MRI). The results of the MMUS (malignant nodes or benign nodes) will be compared with the results of preoperative MRI (malignant or benign lymph nodes) and the final histopathology. The accuracy will be expressed in sensitivity (%), specificity (%) and overall accuracy (% correctly staged lymph nodes) with MMUS and MRI. |
Countries
Sweden
Contacts
Primary ContactCarl-Fredrik Rönnow, MD, PhD
Backup ContactHenrik Thorlacius, Professor
Outcome results
None listed