NCT04622176

Brief Summary

A magnetomotive ultrasound combines standard diagnostic ultrasound equipment with the application of an external time-varying magnetic field. The investigators aim to use this equipment to improve preoperative diagnostics in rectal cancer.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2020

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 9, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

June 17, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

December 8, 2023

Status Verified

December 1, 2023

Enrollment Period

3.5 years

First QC Date

October 23, 2020

Last Update Submit

December 7, 2023

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (2)

  • Accuracy of lymph node diagnosis compared to pathology report

    Accuracy of lymph node diagnosis - a comparison between the findings with the device and the pathology report

    1 hour postoperatively

  • Accuracy of lymph node diagnosis compared to MRI

    Accuracy of lymph node diagnosis compared to MRI

    1 hour postoperatively

Study Arms (1)

Patients with rectal cancer

Patients with rectal cancer will be included and asked to participate in the study where a MMUS will be used after resection to test diagnostic accuracy.

Diagnostic Test: MMUS

Interventions

MMUSDIAGNOSTIC_TEST

MMUS will be used to perform diagnostics, we will compare with MRI and histology

Patients with rectal cancer

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with rectal cancer undergoing abdominoperineal excision.

You may qualify if:

  • Rectal cancer
  • Surgery with abdominoperineal resection

You may not qualify if:

  • No informed consent
  • No rectal cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Eva Angenete

    Sahlgrenska Universitetssjukhuset

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Angenete, MD. PhD

CONTACT

+46760-514441eva.angenete@vgregion.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of surgery

Study Record Dates

First Submitted

October 23, 2020

First Posted

November 9, 2020

Study Start

June 17, 2021

Primary Completion

December 31, 2024

Study Completion

December 1, 2025

Last Updated

December 8, 2023

Record last verified: 2023-12

Locations

SE(1)