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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Information provided by (Responsible Party): | 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.
In a past study, FMISO PET scans were performed in 6 patients with rectal 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: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Screening |
| 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: | 50 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
FMISO PET study.
|
Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
You will be scanned 2 to 3 times on the same day, but you will only be administered one dose of the FMISO tracer. The first scan will last about 30 minutes. Then you will have 1 to 3 hours to wait before you are scanned again. Some patients will undergo a second scan approximately one-and-a-half hours after the start of the first scan. This scan will last about 10 minutes. The final scan will occur between 2-4 hours after the start of the first scan. This final scan will also last about 10 minutes. During the PET scan, you may have a separate i.v. line put into your other arm so that we can take 2 to 3 blood samples. These samples will be less than half a teaspoon each. We are taking these blood samples to see how quickly FMISO leaves your blood stream. The first sample will be taken between 2 and 40 minutes after the FMISO is injected. The other two blood samples will be taken with each subsequent scan.
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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 | |
| Contact: John Humm, PhD | 212-639-7367 |
| United States, New York | |
| Memorial Sloan Kettering Cancer Center | Recruiting |
| New York, New York, United States, 10065 | |
| Contact: Jose Guillem, MD 212-639-8278 | |
| Principal Investigator: Jose Guillem, MD | |
| Principal Investigator: | Jose Guillem, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Responsible Party: | Memorial Sloan-Kettering Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00574353 History of Changes |
| Other Study ID Numbers: | 07-151 |
| Study First Received: | December 13, 2007 |
| Last Updated: | November 3, 2011 |
| Health Authority: | United States: Institutional Review Board |
|
colorectal cancer 07-151 |
|
Rectal Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Rectal Diseases Colonic Diseases Fluorides |
Misonidazole Fluoromisonidazole Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents Therapeutic Uses Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Radiation-Sensitizing Agents |
