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

• ClinicalTrials.gov Identifier: NCT01460641
• Recruitment Status: Completed
• First Posted: October 27, 2011
• Last Update Posted: September 7, 2018
• Sponsor: Stanford University
• Information provided by (Responsible Party): Aya Kamaya, Stanford University

Study Description

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.

Condition or disease
Rectal Cancer

Detailed Description:

Recent advances in computed tomography (CT) technology have made CT perfusion imaging feasible for the assessment of tumor perfusion in solid tumors of the abdomen. CT perfusion has shown promising results in serving as a noninvasive method of predicting response to therapy in cancer patients. CT perfusion parameters have also been found to correlate with immunohistologic markers of angiogenesis in a number of solid tumors, suggesting a possible role for CT perfusion as a noninvasive biomarker of tumor angiogenesis. The goals of the investigators study are twofold: first, to determine the relationship between baseline CT perfusion characteristics of rectal cancers and their response to treatment, and second, to determine if perfusion CT can be used to subsequently monitor tumor response to treatment. The investigators hope to enroll those patients with locally advanced rectal cancer undergoing standard CT for pre-treatment planning, integrating CT perfusion imaging into the current abdomen/pelvis imaging protocol with close clinical and radiologic follow-up after treatment to determine response to therapy and time to disease progression.

Study Design

• Study Type: Observational
• Actual Enrollment: 21 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Perfusion CT as a Predictor of Treatment Response in Patients With Rectal Cancer
• Study Start Date: November 2011
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: July 2018

Groups and Cohorts

Group/Cohort
CT perfusion

Outcome Measures

Primary Outcome Measures :

1. Tumor stage change from Computed Tomography (CT) perfusion measurement [ Time Frame: 3 months ]

Secondary Outcome Measures :

1. Tumor perfusion as measured by perfusion CT. [ Time Frame: 1 year ]

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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

United States, California

Stanford University, School of Medicine

Stanford, California, United States, 94305

Sponsors and Collaborators

Stanford University

Investigators

• Principal Investigator: Aya Kamaya; Stanford University

More Information

• Responsible Party: Aya Kamaya, Associate Professor of Radiology, Stanford University
• ClinicalTrials.gov Identifier: NCT01460641
• Other Study ID Numbers: REC0006; SU-10202011-8538 ( Other Identifier: Stanford University ); 19224 ( Other Identifier: Stanford IRB )
• First Posted: October 27, 2011
• Last Update Posted: September 7, 2018
• Last Verified: September 2018

Additional relevant MeSH terms:

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