Perfusion CT as a Predictor of Treatment Response in Patients With Rectal Cancer

NCT01460641 | Completed DMC

• 3 other identifiers: REC0006SU-10202011-853819224
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

A research study of rectal cancer perfusion (how blood flows to the rectum over time). We hope to learn whether perfusion characteristics of rectal masses may be predictive of response to treatment and whether rectal perfusion characteristics can be used to follow response to treatment.

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

• Tumor stage change from Computed Tomography (CT) perfusion measurement

  3 months

Secondary Outcomes (1)

• Tumor perfusion as measured by perfusion CT.

  1 year

Study Arms (1)

CT perfusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with locally advanced rectal cancer undergoing standard CT for pre-treatment planning

You may qualify if:

• Patients with suspected or biopsy-proven, locally advanced rectal cancer will be eligible for enrollment.
• Patients must be 18 years or older. Patients must not be pregnant and, if of child-bearing age, must take precautions not to become pregnant.
• No life expectancy restrictions.
• ECOG and Karnofsky Performance Status will not be employed.
• Patients with renal failure are ineligible for this study (GFR must be \> 60)
• Ability to understand and willingness to sign a written informed consent document.

You may not qualify if:

• Patients who have undergone prior treatment for rectal cancer are ineligible for enrollment.
• No restrictions regarding use of other investigational agents.
• Patients with severe contrast allergy are ineligible.
• Patients who are pregnant or are trying to become pregnant are excluded from this study.
• Patients who are cancer survivors or HIV-positive will not be excluded.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94305, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

If the patient undergoes surgery to remove the lesion in the rectum, the surgical specimen will be examined by the pathologist, who will perform a variety of tests to detect evidence of new blood vessel growth. The sample will be stored per routine protocol of the Stanford Department of Pathology.

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Aya Kamaya

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 27, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (1)