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”

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.

Study Type: Interventional

Study Design: Screening, Open Label, Active Control, Single Group Assignment, Efficacy Study

Study Primary Completion Date: December 2009

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.

Intervention(s) in this Clinical Trial

• Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
  • For this one study, you will be scanned three times on the same day. The first scan will last about 30 minutes. You will then have an hour to wait before you are scanned again. The second scan will last about 10 minutes. You will have between one and two hours to wait before you are scanned again. The third and 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 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 before the FMISO is injected. Blood samples will then be taken about every minute for the first 5 minutes after the FMISO tracer is injected. After that samples will be taken at about 7, 10, 15, 20, 30, 90, and 180 minutes after the tracer is injected.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • FMISO PET study.

Primary Measures

• the feasibility of a non-invasive method of detecting hypoxia, using FMISO-PET imaging in rectal cancer patients.
  • Time Frame: three times on the same day.
    Safety Issue?: No

Secondary Measures

• determine volume of hypoxic tumor ROIs as a proportion of the entire tumor volume by this non-invasive imaging technique. ROIs are defined as those voxels, within the tumor volume defined on FDG PET/CT, for which the 18F-FMISO radioactivity concent
  • Time Frame: prior to FMISO injection, every minute for the first 5minutes after the FMISO tracer is injected.After that samples will be taken at about 7, 10, 15,20, 30, 90, and 180 minutes after the tracer is injected.
    Safety Issue?: No

Inclusion Criteria:

• Able to provide written informed consent
• Histologically confirmed diagnosis of Stage 2 or Stage 3 rectal carcinoma requiring preoperative radiation, chemotherapy or both, per treating physician
• 18 years of age or older
• Karnofsky performance status ≥ 70

Exclusion Criteria:

• Patients who underwent surgical resection for the same disease (except for biopsy)
• Any prior radiotherapy to the pelvis
• Prior chemotherapy or radiotherapy within the last 3 years
• Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Memorial Sloan-Kettering Cancer Center

Overall Clinical Trial Officials and Contacts

Jose Guillem, MD Principal Investigator Memorial Sloan-Kettering Cancer Center  

Overall Contact: Jose Guillem, MD 212-639-8278 guillemj@mskcc.org

Information obtained from ClinicalTrials.gov on August 29, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00574353

Study ID Number: 07-151

ClinicalTrials.gov Identifier: NCT00574353

Health Authority: United States: Institutional Review Board

Memorial Sloan-Kettering Cancer Center