Trial Outcomes & Findings for Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer (NCT NCT02287675)
NCT ID: NCT02287675
Last Updated: 2020-07-28
Results Overview
The rate of injection site clearance is the time from radiotracer injection to peak SLN radioactive level. Injection clearance rates will be determined by planar SPECT imaging and by SPECT/CT. Subjects will undergo standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
2 hours
Results posted on
2020-07-28
Participant Flow
Participant milestones
| Measure |
Sulfur Colloid
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
Lymphoseek
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
18
|
|
Overall Study
COMPLETED
|
22
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lymphoseek
n=18 Participants
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 Participants
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=18 Participants
|
9 Participants
n=22 Participants
|
22 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=18 Participants
|
13 Participants
n=22 Participants
|
18 Participants
n=40 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=18 Participants
|
22 Participants
n=22 Participants
|
40 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=18 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Height
|
63.97 inches
STANDARD_DEVIATION 2.56 • n=18 Participants
|
65.02 inches
STANDARD_DEVIATION 2.33 • n=22 Participants
|
64.55 inches
STANDARD_DEVIATION 2.46 • n=40 Participants
|
|
Weight
|
193.72 pounds
STANDARD_DEVIATION 38.9 • n=18 Participants
|
178.23 pounds
STANDARD_DEVIATION 41.45 • n=22 Participants
|
185.20 pounds
STANDARD_DEVIATION 40.57 • n=40 Participants
|
|
BMI
|
33.33 kg/m^2
STANDARD_DEVIATION 6.86 • n=18 Participants
|
29.61 kg/m^2
STANDARD_DEVIATION 6.66 • n=22 Participants
|
31.28 kg/m^2
STANDARD_DEVIATION 6.92 • n=40 Participants
|
|
Temperature
|
98.28 Degrees Fahrenheit
STANDARD_DEVIATION 0.52 • n=18 Participants
|
98.19 Degrees Fahrenheit
STANDARD_DEVIATION 0.66 • n=22 Participants
|
98.23 Degrees Fahrenheit
STANDARD_DEVIATION 0.59 • n=40 Participants
|
|
Systolic blood pressure
|
138.22 mmHg
STANDARD_DEVIATION 23.51 • n=18 Participants
|
138.86 mmHg
STANDARD_DEVIATION 22.60 • n=22 Participants
|
138.58 mmHg
STANDARD_DEVIATION 22.72 • n=40 Participants
|
|
Diastolic blood pressure
|
80.61 mmHg
STANDARD_DEVIATION 14.12 • n=18 Participants
|
78.91 mmHg
STANDARD_DEVIATION 15.37 • n=22 Participants
|
79.68 mmHg
STANDARD_DEVIATION 14.66 • n=40 Participants
|
|
pulse
|
81.11 beats per minute
STANDARD_DEVIATION 10.86 • n=18 Participants
|
78.5 beats per minute
STANDARD_DEVIATION 11.31 • n=22 Participants
|
79.68 beats per minute
STANDARD_DEVIATION 11.04 • n=40 Participants
|
|
respiratory rate
|
15.44 breaths per minute
STANDARD_DEVIATION 1.54 • n=18 Participants
|
15.62 breaths per minute
STANDARD_DEVIATION 2.04 • n=22 Participants
|
15.54 breaths per minute
STANDARD_DEVIATION 1.80 • n=40 Participants
|
PRIMARY outcome
Timeframe: 2 hoursThe rate of injection site clearance is the time from radiotracer injection to peak SLN radioactive level. Injection clearance rates will be determined by planar SPECT imaging and by SPECT/CT. Subjects will undergo standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes.
Outcome measures
| Measure |
Lymphoseek
n=18 Participants
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 Participants
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Injection Site Clearance for Lymphoseek and 99mTc-Sulfur Colloid (SC).
|
1.78 minutes
Standard Deviation 0.85
|
0.045 minutes
Standard Deviation 0.18
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PRIMARY outcome
Timeframe: 2 hoursSLN uptake rates will be determined by planar SPECT (single-photon emission computerized tomography) imaging and by SPECT/CT (CT-computed tomography). Gamma counts will be obtained at the injection site by standard sequential planar imaging at 30 to 60 seconds intervals until the sentinel lymph node is seen. Once a sentinel node is located, a SPECT/CT will be performed for higher resolution imaging in transaxial, coronal, and sagittal planes. Figures showing the percent of peak activity in the node versus time will be constructed for each radiopharmaceutical. The average uptake rate for each radiopharmaceutical will be computed and the following test will be conducted using a two-sample t-test at a two-sided α=0.05 (one-sided α=0.025) level of significance: H0 (null hypothesis): µLS ≤ µSC vs. HA (alternative hypothesis): µLS \> µSC, (µLS is the average SLN uptake rate of Lymphoseek) (µSC is the average SLN uptake rate of 99mTc Sulfur Colloid).
Outcome measures
| Measure |
Lymphoseek
n=18 Participants
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 Participants
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Sentinel Lymph Node Uptake Rate
|
59.28 minutes
Standard Deviation 44.02
|
86.46 minutes
Standard Deviation 54.15
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Lymph Nodes Removed Intraoperative
To compare the number of intraoperatively detected SLNs identified by Lymphoseek and 99mTc-SC on an agent cohort basis
Outcome measures
| Measure |
Lymphoseek
n=28 Lymph Nodes
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=32 Lymph Nodes
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Number of Intraoperatively Detected Sentinel Lymph Nodes (SLNs) Identified
|
9 Lymph Nodes
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22 Lymph Nodes
|
SECONDARY outcome
Timeframe: 24 hoursTo compare differences in the ratio of intraoperative counts for Lymphoseek vs 99mTc-SC for the hottest harvested axillary Sentinel Lymph Node (SLN) relative to the primary intradermal injection site.
Outcome measures
| Measure |
Lymphoseek
n=18 Participants
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 Participants
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Ratio of Intraoperative Gamma Counts
|
0.1093 Ratio
Standard Deviation 0.0917
|
0.2621 Ratio
Standard Deviation 0.6105
|
SECONDARY outcome
Timeframe: 24 hoursTo compare patient pain tolerance (i.e., patient's perceived level of discomfort) at the injection site for Lymphoseek vs 99mTc-SC using Wong-Baker pain rating scale of 0-10, where the higher the score, the higher the pain level.
Outcome measures
| Measure |
Lymphoseek
n=18 Participants
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 Participants
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Patient Pain Tolerance
|
0.5278 score on a scale
Standard Deviation 0.88238
|
1.5682 score on a scale
Standard Deviation 2.17286
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: Intraoperative Lymph Nodes extracted with presence of radiotracer
To compare pathologic assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases for Lymphoseek vs 99mTc-SC.
Outcome measures
| Measure |
Lymphoseek
n=9 Lymph Nodes
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 Lymph Nodes
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Pathologic Assessment of the Excised Lymph Node(s)
Positive for tumor metastasis
|
2 Lymph Nodes
|
0 Lymph Nodes
|
|
Pathologic Assessment of the Excised Lymph Node(s)
Negative for tumor metastasis
|
7 Lymph Nodes
|
22 Lymph Nodes
|
Adverse Events
Lymphoseek
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Sulfur Colloid
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lymphoseek
n=18 participants at risk
Lymphoseek (technetium Tc 99m tilmanocept) Injection is indicated for lymphatic mapping with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma and guiding sentinel lymph node biopsy using a hand-held gamma counter in patients with clinically node negative squamous cell carcinoma of the oral cavity.
|
Sulfur Colloid
n=22 participants at risk
Technetium Tc 99m Sulfur Colloid Injection is a radioactive diagnostic agent indicated for use as follows:
In adults, to assist in the:
* localization of lymph nodes draining a primary tumor in patients with
* breast cancer or malignant melanoma when used with a hand-held gamma counter.
* evaluation of peritoneovenous (LeVeen) shunt patency in adults.
|
|---|---|---|
|
Nervous system disorders
Intermittent headaches
|
0.00%
0/18 • From screening through follow-up, up to 50 days
|
4.5%
1/22 • Number of events 1 • From screening through follow-up, up to 50 days
|
|
Gastrointestinal disorders
Nausea
|
5.6%
1/18 • Number of events 1 • From screening through follow-up, up to 50 days
|
4.5%
1/22 • Number of events 1 • From screening through follow-up, up to 50 days
|
|
Gastrointestinal disorders
Vomiting
|
5.6%
1/18 • Number of events 1 • From screening through follow-up, up to 50 days
|
4.5%
1/22 • Number of events 1 • From screening through follow-up, up to 50 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place