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. (see Contacts and Locations)
Verified June 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00574353
First received: December 13, 2007
Last updated: June 3, 2014
Last verified: June 2014
  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 2

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

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 F-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-F-FMISO radioactivity concent [ Time Frame: prior to F-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: 50
Study Start Date: December 2007
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00574353

Contacts
Contact: Jose Guillem, MD 212-639-8278
Contact: John Humm, PhD 212-639-7367

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      
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
ClinicalTrials.gov Identifier: NCT00574353     History of Changes
Other Study ID Numbers: 07-151
Study First Received: December 13, 2007
Last Updated: June 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
colorectal cancer
07-151

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
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

ClinicalTrials.gov processed this record on July 20, 2014