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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

Information source: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Colorectal Cancer

Intervention: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission (Radiation)

Phase: Phase 2

Status: Recruiting

Sponsored by: Memorial Sloan Kettering Cancer Center

Official(s) and/or principal investigator(s):
Jose Guillem, MD, Principal Investigator, Affiliation: Memorial Sloan Kettering Cancer Center

Overall contact:
Jose Guillem, MD, Phone: 212-639-8278

Summary

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.

Clinical Details

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

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Primary outcome: the feasibility of a non-invasive method of detecting hypoxia, using F-FMISO-PET imaging in colorectal cancer patients.

Secondary outcome: 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

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Jose Guillem, MD, Phone: 212-639-8278

Memorial Sloan Kettering Cancer Center, New York, New York 10065, United States; Recruiting
Jose Guillem, MD, Phone: 212-639-8278
Jose Guillem, MD, Principal Investigator
Additional Information

Memorial Sloan Kettering Cancer Center

Starting date: December 2007
Last updated: May 7, 2015

Page last updated: August 23, 2015

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