Clinical trial NCT00574353: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer
07-151
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-17
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

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 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

Primary outcomes:
measure: Number of Participants Successfully Scanned Using F-FMISO-PET Imaging
timeFrame: Post injection between 0-30 min, and again at the nominal times of 90 min and 180 min
Secondary outcomes:
measure: Number of Participants Who Had Blood Samples Collected
timeFrame: Up to 180 minutes post injection
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: John Humm, PhD
role: PRINCIPAL_INVESTIGATOR
References: