Ultrasound Elastography in Patients With Rectal Cancer

NCT ID: NCT01379612

Last Updated: 2013-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2012-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Rectal cancer patients in chemoradiation

Ultrasonic Elastography

Intervention Type OTHER

Non-invasive

Interventions

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Ultrasonic Elastography

Non-invasive

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vejle Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dept. of Oncology, Vejle Hospital

Vejle, , Denmark

Site Status

Dept. of Radiology, Vejle Hospital

Vejle, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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S-20100028

Identifier Type: -

Identifier Source: org_study_id

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