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OpenTrials
Completed

NCT Number: NCT01379612

Ultrasound Elastography in Patients With Rectal Cancer

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.

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Key information

Conditions

Rectal Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. of Oncology, Vejle Hospital, Vejle, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Ultrasonic Elastography

Other

Non-invasive

Primary outcomes

  1. Tumor regression grade

    Time frame: 8 weeks after operation

Sponsors and collaborators

Lead sponsor

Vejle Hospital

Other

Registry information

Official study title

Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 23, 2011
Registry last updated
Jun 17, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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