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NCT01379612 Clinical Trial

Ultrasound Elastography in Patients With Rectal Cancer

Rectal Cancer Clinical Trial

Official title:
Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01379612
Other study ID # S-20100028
Secondary ID
Status Completed
Phase N/A
First received June 8, 2011
Last updated June 14, 2013
Start date May 2010
Est. completion date December 2012

Study information
Verified date June 2013
Source Vejle Hospital
Contact n/a
Is FDA regulated No
Health authority Denmark: Ethics CommitteeDenmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date December 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• Ultrasonic Elastography
Non-invasive

Locations
Country Name City State
Denmark Dept. of Oncology, Vejle Hospital Vejle
Denmark Dept. of Radiology, Vejle Hospital Vejle

Sponsors (1)
Lead Sponsor Collaborator
Vejle Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Tumor regression grade 8 weeks after operation No
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