- ICH GCP
- US Clinical Trials Registry
- 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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
FMISO PET study.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
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three times on the same day.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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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
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Collaborators and Investigators
Investigators
- Principal Investigator: John Humm, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Colonic Diseases
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Signs and Symptoms, Respiratory
- Colorectal Neoplasms
- Hypoxia
- Anti-Infective Agents
- Antineoplastic Agents
- Antiprotozoal Agents
- Antiparasitic Agents
- Misonidazole
Other Study ID Numbers
- 07-151
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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