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
| Status: | Withdrawn |
|---|---|
| Conditions: | Colorectal Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/14/2018 |
| Start Date: | December 2007 |
| End Date: | December 2019 |
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.
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.
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.
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.
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.
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
We found this trial at
1
site
1275 York Ave
New York, New York 10021
New York, New York 10021
(212) 639-2000
Principal Investigator: Jose Guillem, MD
Phone: 212-639-8278
Memorial Sloan Kettering Cancer Center Memorial Sloan Kettering Cancer Center — the world's oldest and...
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