| December 13, 2007 |
| June 19, 2009 |
| December 2007 |
| December 2010 (final data collection date for primary outcome measure) |
| 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 ] |
| the feasibility of a non-invasive method of detecting hypoxia, using FMISO-PET imaging in rectal cancer patients. [ Time Frame: three times on the same day. ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00574353 on ClinicalTrials.gov Archive Site |
| 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 Btw 1 & 3 cc of blood will be taken at each time point (making the max volume of blood withdrawn during this study 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 ] |
| 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, every minute for the first 5minutes after the FMISO tracer is injected.After that samples will be taken at about 7, 10, 15,20, 30, 90, and 180 minutes after the tracer is injected. ] [ Designated as safety issue: No ] |
| |
| 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 |
| 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.
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. |
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. |
| Phase II |
| Interventional |
| Screening, Open Label, Active Control, Single Group Assignment, Efficacy Study |
| Colorectal Cancer |
| Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission |
| Experimental: FMISO PET study. |
| |
| |
| Recruiting |
| 30 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
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
|
| Both |
| 18 Years and older |
| No |
|
|
| United States |
| |
| NCT00574353 |
| Jose Guillem, MD, Memorial Sloan-Kettering Cancer Center |
| 07-151 |
| Memorial Sloan-Kettering Cancer Center |
|
| Principal Investigator: |
Jose Guillem, MD |
Memorial Sloan-Kettering Cancer Center |
|
|
| Memorial Sloan-Kettering Cancer Center |
| June 2009 |
