Trial Outcomes & Findings for Feasibility of Using SPECT/CT Imaging to Map Lymphatic Drainage Patterns in Prostate Cancer Patients (NCT NCT01008969)
NCT ID: NCT01008969
Last Updated: 2012-02-02
Results Overview
Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.
COMPLETED
NA
10 participants
1 day
2012-02-02
Participant Flow
Participant milestones
| Measure |
99mTc-sulfur Nanocolloid SPECT/CT
SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility of Using SPECT/CT Imaging to Map Lymphatic Drainage Patterns in Prostate Cancer Patients
Baseline characteristics by cohort
| Measure |
99mTc-sulfur Nanocolloid SPECT/CT
n=10 Participants
SPECT/CT imaging of administered 99mTc-sulfur nanocolloid within 3 hours after injection in patients with prostate cancer
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
|
Age Continuous
|
71.5 years
STANDARD_DEVIATION 8.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: We reviewed the imaging results of this procedure by SPECT/CT. Percentage of participants who received SPECT/CT scans of 99mTc-sulfur nanocolloid was analyzed.
Successful completion of 99mTc-sulfur nanocolloid SPECT/CT means that the images were obtained within 3 hours, and the images showed patients' lymphatic drainage.
Outcome measures
| Measure |
99mTc-sulfur Nanocolloid SPECT/CT
n=10 Participants
There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
|
|---|---|
|
Percentage of Participants Successfully Completed 99mTc-sulfur Nanocolloid SPECT/CT Within 3 Hours After Injection
|
100 Percentage of Participants
|
SECONDARY outcome
Timeframe: 1 dayPopulation: We reviewed the imaging results of this procedure by SPECT/CT. We calculated the percentage of images with detectable lymph nodes from SPECT/CT images in these participants.
There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection. The imaging studies qualitatively detected radiotracer distribution within the prostate and local lymphatic system. The detection of the radiotracer distribution was performed by experienced attending nuclear medicine physicians at UCSF. The qualitative detection includes visual lymph node uptake seen by SPECT scans overlaid on coregistered CT scans.
Outcome measures
| Measure |
99mTc-sulfur Nanocolloid SPECT/CT
n=10 Participants
There was only one arm for this study. All participants who had prostate cancer received 99mTc-sulfur nanocolloid injection and imaged by SPECT/CT within 3 hours of injection.
|
|---|---|
|
Percentage of Images With Detectable Sentinel Lymph Nodes (LNs) From 99mTc-sulfur Nanocolloid SPECT/CT Scans
|
100 percentage of images identifying LNs
|
Adverse Events
99mTc-sulfur Nanocolloid SPECT/CT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Youngho Seo, PhD
University of California, San Francisco
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place