Ultrasound Elastography in Patients With Rectal Cancer

June 14, 2013 updated by: Vejle Hospital

Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation

The aim of this study is to recruit 50 rectal cancer patients planned to receive standard radiochemotherapy. A baseline ultrasonic elastography is performed prior to radiochemotherapy and followed by re-scans two and six weeks after initiation of treatment. The objective quantitative elastography findings are compared with the TRG score.

The purpose is to elucidate ultrasonic elastography's ability to predict treatment response at an early stage by comparing quantitative ultrasound parameters before, during and after treatment with MR scan results and histopathological Tumor Regression Grade (TRG score) after operation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

31

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Vejle, Denmark, 7100
        • Dept. of Oncology, Vejle Hospital
      • Vejle, Denmark, 7100
        • Dept. of Radiology, Vejle Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Rectal cancer patients planned for preoperative chemoradiation at the Dept. of Oncology, Vejle Hospital, Denmark.

Description

Inclusion Criteria:

  1. Patients with biopsy verified adenocarcinoma in the rectum ≤ 10 cm from the anal verge.
  2. T3/4 tumor assessed by transrectal ultrasound and MR, and CRMMR < 5 mm.
  3. Life expectancy of more than 3 months.
  4. Age ≥18 years.
  5. Performance status ≤ 2 according to WHO.
  6. Patient able to observe protocol guidelines.
  7. Signed informed consent.

Exclusion Criteria:

  1. Previous radiation treatment for the pelvis.
  2. Known distant metastases.
  3. Serious disease contraindicating treatment, including cardiovascular disease.
  4. Other malignant disease apart from curativly treated non-melanotic skin cancer and previously treated carcinoma in situ cervicis uteri.
  5. Pacemaker
  6. other disease making the patient unfit for study participation as assessed by investigator

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rectal cancer patients in chemoradiation
Other: Ultrasonic Elastography
Non-invasive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tumor regression grade
Time Frame: 8 weeks after operation
8 weeks after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vejle Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

June 8, 2011

First Submitted That Met QC Criteria

June 21, 2011

First Posted (ESTIMATE)

June 23, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

June 17, 2013

Last Update Submitted That Met QC Criteria

June 14, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S-20100028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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