Ultrasound Elastography in Patients With Rectal Cancer

• Sponsor: Vejle Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01379612
• Collaborator: (none)
• Enrollment: 31
• Locations: 2
• Duration (Months): 31
• Patients Per Site: 15.5
• Patients Per Site Per Month: 0.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Other: Ultrasonic Elastography

Study Design

• Study Type: Observational
• Actual Enrollment: 31 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: Ultrasound Elastography of Rectal Cancer Patients Treated With Preoperative Chemoradiation
• Study Start Date: May 1, 2010
• Actual Primary Completion Date: Jun 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Rectal cancer patients in chemoradiation	Other: Ultrasonic Elastography; Non-invasive

Outcome Measures

Primary Outcome Measures

1. Tumor regression grade [8 weeks after operation]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Oncology, Vejle Hospital	Vejle		Denmark	7100
2	Dept. of Radiology, Vejle Hospital	Vejle		Denmark	7100

Sponsors and Collaborators

• Vejle Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Vejle Hospital
• ClinicalTrials.gov Identifier: NCT01379612
• Other Study ID Numbers: S-20100028
• First Posted: Jun 23, 2011
• Last Update Posted: Jun 17, 2013
• Last Verified: Jun 1, 2013

• Keywords provided by Vejle Hospital: Ultrasound elastography; Rectal cancer; Preoperative chemoradiation
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Jun 17, 2013