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

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stanford University Identifier:
First received: October 21, 2011
Last updated: September 21, 2016
Last verified: September 2016
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.

Rectal Cancer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Perfusion CT as a Predictor of Treatment Response in Patients With Rectal Cancer

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Tumor stage change from Computed Tomography (CT) perfusion measurement [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • 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.

Enrollment: 21
Study Start Date: November 2011
Estimated Study Completion Date: July 2018
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
CT perfusion

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

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
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Please refer to this study by its identifier: NCT01460641

United States, California
Stanford University, School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Aya Kamaya Stanford University
  More Information

Responsible Party: Stanford University Identifier: NCT01460641     History of Changes
Other Study ID Numbers: REC0006
SU-10202011-8538 ( Other Identifier: Stanford University )
19224 ( Other Identifier: Stanford IRB )
Study First Received: October 21, 2011
Last Updated: September 21, 2016

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases processed this record on June 23, 2017