Magnetomotoric Ultrasound (MMUS) in Rectal Cancer (MAMORECT)
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|ClinicalTrials.gov Identifier: NCT05052086|
Recruitment Status : Recruiting
First Posted : September 22, 2021
Last Update Posted : September 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Diagnostic Test: Magnetomotoric ultrasound||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|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.|
|Masking:||None (Open Label)|
|Official Title:||Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer|
|Estimated Study Start Date :||October 1, 2021|
|Estimated Primary Completion Date :||December 20, 2022|
|Estimated Study Completion Date :||March 1, 2023|
Experimental: Magnetomotoric ultrasound
Magnetomotoric ultrasound in addition to MRI.
Diagnostic Test: Magnetomotoric ultrasound
Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.
- Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05052086
|Contact: Carl-Fredrik Rönnow, MD, PhDfirstname.lastname@example.org|
|Contact: Henrik Thorlacius, Professor||+46 email@example.com|