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Ultrasound Elastography in Patients With Rectal Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01379612
First Posted: June 23, 2011
Last Update Posted: June 17, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Vejle Hospital
  Purpose

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.


Condition Intervention
Rectal Cancer Other: Ultrasonic Elastography

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation

Resource links provided by NLM:


Further study details as provided by Vejle Hospital:

Primary Outcome Measures:
  • Tumor regression grade [ Time Frame: 8 weeks after operation ]

Enrollment: 31
Study Start Date: May 2010
Study Completion Date: December 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Rectal cancer patients in chemoradiation Other: Ultrasonic Elastography
Non-invasive

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Rectal cancer patients planned for preoperative chemoradiation at the Dept. of Oncology, Vejle Hospital, Denmark.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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): NCT01379612


Locations
Denmark
Dept. of Oncology, Vejle Hospital
Vejle, Denmark, 7100
Dept. of Radiology, Vejle Hospital
Vejle, Denmark, 7100
Sponsors and Collaborators
Vejle Hospital
  More Information

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01379612     History of Changes
Other Study ID Numbers: S-20100028
First Submitted: June 8, 2011
First Posted: June 23, 2011
Last Update Posted: June 17, 2013
Last Verified: June 2013

Keywords provided by Vejle Hospital:
Ultrasound elastography
Rectal cancer
Preoperative chemoradiation

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases