Trial Outcomes & Findings for 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 (NCT NCT00574353)
NCT ID: NCT00574353
Last Updated: 2025-05-09
Results Overview
The uptake kinetics of \[18F\]-Fluoromisonidazole activity in the colorectal lesion was entered into a compartmental model to determine the rate constants of uptake (k1) and irreversible binding (k3) in the lesion on the PET scan at different times post injection. Also the tumor to background ratio was determine. A plot of k3 and TNB was plotted. This will help determine the Feasibility of a Non-invasive Method of Detecting Hypoxia, Using F-FMISO-PET Imaging in Colorectal Cancer Patients.
COMPLETED
NA
23 participants
Post injection between 0-30 min, and again at the nominal times of 90 min and 180 min
2025-05-09
Participant Flow
Participant milestones
| Measure |
FMISO PET Study
FMISO PET study.
Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
23
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
FMISO PET Study
n=23 Participants
FMISO PET study.
Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
|
|---|---|
|
Age, Continuous
|
54 years
n=99 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Post injection between 0-30 min, and again at the nominal times of 90 min and 180 minThe uptake kinetics of \[18F\]-Fluoromisonidazole activity in the colorectal lesion was entered into a compartmental model to determine the rate constants of uptake (k1) and irreversible binding (k3) in the lesion on the PET scan at different times post injection. Also the tumor to background ratio was determine. A plot of k3 and TNB was plotted. This will help determine the Feasibility of a Non-invasive Method of Detecting Hypoxia, Using F-FMISO-PET Imaging in Colorectal Cancer Patients.
Outcome measures
| Measure |
FMISO PET Study
n=23 Participants
FMISO PET study.
Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
|
|---|---|
|
Number of Participants Successfully Scanned Using F-FMISO-PET Imaging
Participants successfully scanned
|
18 Participants
|
|
Number of Participants Successfully Scanned Using F-FMISO-PET Imaging
Participants not scanned
|
5 Participants
|
SECONDARY outcome
Timeframe: Up to 180 minutes post injectionBlood sample was taken in order to determine the blood pharmacokinetics of \[18F\]-Fluoromisonidazole in these participants.
Outcome measures
| Measure |
FMISO PET Study
n=23 Participants
FMISO PET study.
Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission
|
|---|---|
|
Number of Participants Who Had Blood Samples Collected
Blood sample collected
|
10 Participants
|
|
Number of Participants Who Had Blood Samples Collected
Blood sample was not collected
|
13 Participants
|
Adverse Events
FMISO PET Study
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. John Humm, PhD
Memorial Sloan Kettering Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place