Ultrasound Elastography in Patients With Rectal Cancer
Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation
1 other identifier
observational
31
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2010
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
June 8, 2011
CompletedFirst Posted
Study publicly available on registry
June 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedJune 17, 2013
June 1, 2013
2.1 years
June 8, 2011
June 14, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tumor regression grade
8 weeks after operation
Study Arms (1)
Rectal cancer patients in chemoradiation
Interventions
Eligibility Criteria
Rectal cancer patients planned for preoperative chemoradiation at the Dept. of Oncology, Vejle Hospital, Denmark.
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vejle Hospitallead
Study Sites (2)
Dept. of Oncology, Vejle Hospital
Vejle, 7100, Denmark
Dept. of Radiology, Vejle Hospital
Vejle, 7100, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 8, 2011
First Posted
June 23, 2011
Study Start
May 1, 2010
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
June 17, 2013
Record last verified: 2013-06