Rectal CancerMAMORECTNCT05052086
Magnetomotoric Ultrasound (MMUS) in Rectal Cancer
A study testing Magnetomotoric ultrasound in people with Rectal Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Magnetomotoric ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 1 Nov 2022to 1 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rectal cancer
- Scheduled for total mesorectal surgery
- Informed consent
Who cannot join
- Not able to give informed consent
- Synchronus colorectal cancer
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Skane University Hospital, Malmö, section of Surgery
Malmö, Skåne County, 20501
Carl-Fredrik Rönnow, MD, PhD, +46 40-331635, carl-fredrik.ronnow@med.lu.se
Henrik Thorlacius, Professor, +46 40-331000, henrik.thorlacius@med.lu.se
About this study
Official title: Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer
Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Magnetomotoric ultrasound
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetomotoric ultrasoundDiagnostic test
Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.
| Study group | Role | What they receive |
|---|---|---|
| Magnetomotoric ultrasound | Experimental | Magnetomotoric ultrasound in addition to MRI. Receives: Diagnostic Test: Magnetomotoric ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology
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)
Measured: Approximately 1 hour after MMUS
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI
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.
Measured: Approximately 1 hour after MMUS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start1 Nov 2022
- Primary completion20 Dec 2024 (estimated)
- Study completion1 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05052086
- Sponsor's protocol ID
- MAMORECT
- Acronym
- MAMORECT
- Status last verified
- Apr 2024
- First submitted
- 6 Sep 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer
- ClinicalTrials.gov ID
- NCT05052086
- Acronym / sponsor ID
- MAMORECT / MAMORECT
- Conditions
- Rectal Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 20 Dec 2024 (estimated)
- Study completion
- 1 Jan 2025 (estimated)
- First posted
- 22 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Magnetomotoric ultrasound | Experimental | Diagnostic Test: Magnetomotoric ultrasoundMagnetomotoric ultrasound in addition to MRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Rectal cancer
- Scheduled for total mesorectal surgery
- Informed consent
Key exclusion criteria (2 listed)
- Not able to give informed consent
- Synchronus colorectal cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetomotoric ultrasoundNanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized. | Diagnostic test | Magnetomotoric ultrasound |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetomotoric ultrasound in people with Rectal Cancer, run by Region Skane at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carl-Fredrik Rönnow, MD, PhD (+4640-331635, carl-fredrik.ronnow@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology (time frame: Approximately 1 hour after MMUS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.