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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00574353 |
Purpose
When used with a different radioactive tracer called FMISO, a PET scan can find areas of low oxygen in the tumor. We think that having areas of low oxygen is a reason why some tumors are hard to treat with radiation.
FMISO PET scans have been done in 6 patients with rectal cancer. These patients had cancer that could not be operated on and that had spread to other areas. In this group of patients, FMISO PET scans were able to find the low oxygen areas in their tumors. But this study included only a few patients. In the present study, we want to use FMISO PET scans in patients who have tumors that can be operated on. This group of patients will have radiation, chemotherapy or both before they have their surgery. We want to see if FMISO PET can find low oxygen areas in this distinct group of patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission |
Phase II |
| Study Type: | Interventional |
| Study Design: | Screening, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Official Title: | A Feasibility Study Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography to Detect Hypoxia in Locally Advanced (T3-T4 and./or N1)Primary Rectal Cancer Patients |
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
FMISO PET study.
|
Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
You will be scanned three times on the same day. The 1st scan will last about 30 minutes. Then have an hour to wait before you are scanned again. The second scan will last about 10 minutes. You have between one and two hours to wait before you are scanned again. The third & final scan will also last about 10 minutes. During the PET scan, you will have a separate i.v. line put into your other arm so that we can take up to 3 blood samples. These samples will be less than half a teaspoon each. We are taking these blood samples to see how your body responds to FMISO. The first sample will be taken between 2 and 40 minutes after the FMISO is injected. The other two blood samples will be taken 80-100 minutes and again 110-140 minutes after the FMISO injection.
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Hypoxia is a characteristic feature of malignant solid tumors associated with poor prognosis and resistance to chemotherapy and radiation. It has also been shown (6) that the presence of hypoxia may reduce long-term survival post surgery. Hypoxia renders tumor cells up to three times more resistant to ionizing radiation than aerobic cells. The presence of hypoxic regions within tumors may be one factor leading to local failure after treatment with standard pre-operative radiotherapy doses. If these regions could be identified and verified using a non-invasive imaging technique prior to surgery, they could be specifically targeted using sophisticated planning techniques such as intensity modulated radiation therapy (IMRT) to deliver higher doses ionizing radiation with preoperative radiotherapy. Future studies using IMRT to "dose paint" areas of hypoxia within tumors will build upon the results of this feasibility study. Ultimately, by the delivery of differential dose of radiation to the tumor, in combination with surgery, the local control rates of rectal cancer patients may further be improved.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Jose Guillem, MD | 212-639-8278 | guillemj@mskcc.org |
| Contact: John Humm, PhD | 212-639-7367 | hummj@mskcc.org |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Jose Guillem, MD 212-639-8278 guillemj@mskcc.org | |
| Principal Investigator: Jose Guillem, MD | |
| Principal Investigator: | Jose Guillem, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Jose Guillem, MD ) |
| Study ID Numbers: | 07-151 |
| Study First Received: | December 13, 2007 |
| Last Updated: | June 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00574353 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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colorectal cancer |
|
Anti-Infective Agents Antiprotozoal Agents Gastrointestinal Diseases Rectal Neoplasms Antineoplastic Agents Ro 07-0741 Colonic Diseases Physiological Effects of Drugs Rectal Diseases Antiparasitic Agents Neoplasms by Site Cariostatic Agents Therapeutic Uses |
Misonidazole Fluorides Digestive System Neoplasms Intestinal Diseases Protective Agents Intestinal Neoplasms Pharmacologic Actions Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Gastrointestinal Neoplasms Colorectal Neoplasms |