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
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|ClinicalTrials.gov Identifier: NCT00574353|
Recruitment Status : Recruiting
First Posted : December 17, 2007
Last Update Posted : October 26, 2017
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 or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Radiation: Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2007|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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.
- 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. ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00574353
|Contact: Jose Guillem, MD||212-639-8278|
|Contact: John Humm, PhD||212-639-7367|
|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|
|Principal Investigator:||Jose Guillem, MD||Memorial Sloan Kettering Cancer Center|