Ultrasound Elastography in Patients With Rectal Cancer

Vejle Hospital

Status: Completed

Conditions: Rectal Cancer

Treatments: Other: Ultrasonic Elastography

Study type: Observational

Funder types: Other

Identifiers

NCT01379612

S-20100028

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

31 participants in 1 patient group

Rectal cancer patients in chemoradiation

Treatment:

Other: Ultrasonic Elastography