Ultrasound Elastography in Patients With Rectal Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Vejle Hospital
ClinicalTrials.gov Identifier:
NCT01379612
First received: June 8, 2011
Last updated: June 14, 2013
Last verified: June 2013
  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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01379612

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

No publications provided

Responsible Party: Vejle Hospital
ClinicalTrials.gov Identifier: NCT01379612     History of Changes
Other Study ID Numbers: S-20100028
Study First Received: June 8, 2011
Last Updated: June 14, 2013
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

ClinicalTrials.gov processed this record on August 21, 2014