Perfusion CT as a Predictor of Treatment Response in Patients With Rectal Cancer
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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 |
- Tumor stage change from Computed Tomography (CT) perfusion measurement [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- 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 |
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| Contact: Cristian Barquero | 650-736-0798 | cbarquer@stanford.edu |
| United States, California | |
| Stanford University Cancer Institute | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Stanford Cancer Clinical Trials Office 650-498-7061 ccto-office@stanford.edu | |
| Principal Investigator: Aya Kamaya, MD | |
| 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: | January 18, 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 May 23, 2013