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

This study is currently recruiting participants.
Verified October 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01460641
First received: October 21, 2011
Last updated: October 24, 2013
Last verified: October 2013
  Purpose

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.


Condition
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

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Tumor stage change from Computed Tomography (CT) perfusion measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Tumor perfusion as measured by perfusion CT. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 25
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
CT perfusion

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01460641

Locations
United States, California
Stanford University Cancer Institute Recruiting
Stanford, California, United States, 94305
Contact: Laurie Ann Columbo    650-736-0792    lcolumbo@stanford.edu   
Principal Investigator: Aya Kamaya, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Aya Kamaya Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01460641     History of Changes
Other Study ID Numbers: REC0006, SU-10202011-8538, 19224
Study First Received: October 21, 2011
Last Updated: October 24, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014