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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
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, June 2009
First Received: December 13, 2007   Last Updated: June 19, 2009   History of Changes
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • the feasibility of a non-invasive method of detecting hypoxia, using FMISO-PET imaging in colorectal cancer patients. [ Time Frame: three times on the same day. ] [ Designated as safety issue: No ]

Secondary Outcome 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, btw 2-40 min post injection, (ii) btw 80-100 min post injection & (iii) btw 110- 140 min post injection. Btw 1 & 3 cc of blood will be taken at each time point (making the max volume of blood withdrawn during this study < 9 cc). ] [ Designated as safety issue: No ]

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.

Detailed Description:

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
Criteria

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 ≥ or = to 70

Exclusion Criteria:

  • Women who are pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00574353

Contacts
Contact: Jose Guillem, MD 212-639-8278 guillemj@mskcc.org
Contact: John Humm, PhD 212-639-7367 hummj@mskcc.org

Locations
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            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Jose Guillem, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by Memorial Sloan-Kettering Cancer Center:
colorectal cancer

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on November 30, 2009