Trial Outcomes & Findings for Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients. (NCT NCT01276054)
NCT ID: NCT01276054
Last Updated: 2014-08-01
Results Overview
LE is defined using the CTCAE v3 definition: a \>5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
4 participants
Primary outcome timeframe
During the first year post-operatively
Results posted on
2014-08-01
Participant Flow
Recruitment for this trial opened in December 2010 and closed in June 2011 at which time the protocol was terminated due to the departure of the Principal Investigator.
The study has no pre-assignment.
Participant milestones
| Measure |
SNB Plus ARM or ALND (+/- SNB) Plus ARM
Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping
|
SNB or ALND (+/- SNB)
Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
2
|
2
|
Reasons for withdrawal
| Measure |
SNB Plus ARM or ALND (+/- SNB) Plus ARM
Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping
|
SNB or ALND (+/- SNB)
Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
Overall Study
No one to oversee trial after P.I. left
|
2
|
2
|
Baseline Characteristics
Sentinel and/or Axillary Lymph Node Biopsy With or Without Axillary Reverse Mapping in Reducing Incidence and Severity of Arm Lymphedema in Stage 0-2 Patients.
Baseline characteristics by cohort
| Measure |
SNB Plus ARM or ALND (+/- SNB) Plus ARM
n=2 Participants
Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping
|
SNB or ALND (+/- SNB)
n=2 Participants
Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
4 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the first year post-operativelyPopulation: Unable to analyze due to early termination of the study
LE is defined using the CTCAE v3 definition: a \>5-10% increase in the inter-limb volume in the ipsilateral arm compared to the unaffected arm.
Outcome measures
Outcome data not reported
Adverse Events
SNB Plus ARM or ALND (+/- SNB) Plus ARM
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
SNB or ALND (+/- SNB)
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SNB Plus ARM or ALND (+/- SNB) Plus ARM
n=2 participants at risk
Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping
|
SNB or ALND (+/- SNB)
n=2 participants at risk
Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 3 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 2 • Up to 6 months from date on study
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 2 • Up to 6 months from date on study
|
0.00%
0/2 • Up to 6 months from date on study
|
|
General disorders
Edema - limbs
|
50.0%
1/2 • Number of events 1 • Up to 6 months from date on study
|
0.00%
0/2 • Up to 6 months from date on study
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/2 • Up to 6 months from date on study
|
50.0%
1/2 • Number of events 2 • Up to 6 months from date on study
|
Other adverse events
| Measure |
SNB Plus ARM or ALND (+/- SNB) Plus ARM
n=2 participants at risk
Patients undergo sentinel lymph node biopsy (SNB) and/or axillary lymph node biopsy (ALND) using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node. Patients then undergo an axillary reverse mapping.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
lymphedema management: Undergo axillary reverse mapping
|
SNB or ALND (+/- SNB)
n=2 participants at risk
Patients undergo SNB and/or ALND using technetium Tc 99m sulfur colloid followed by methylene blue or indocyanine green solution tracer for localization of the arm lymph node.
technetium Tc 99m sulfur colloid: Given intradermally and periareolarly
methylene blue: Given subcutaneously
indocyanine green solution: Given subcutaneously
sentinel lymph node biopsy: Undergo sentinel lymph node biopsy
axillary lymph node biopsy: Undergo axillary lymph node biopsy
bioimpedance spectroscopy: Correlative studies
quality-of-life assessment: Ancillary studies
|
|---|---|---|
|
General disorders
Pain
|
100.0%
2/2 • Number of events 5 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 4 • Up to 6 months from date on study
|
|
Nervous system disorders
Dizziness
|
50.0%
1/2 • Number of events 1 • Up to 6 months from date on study
|
0.00%
0/2 • Up to 6 months from date on study
|
|
General disorders
Fatigue
|
100.0%
2/2 • Number of events 3 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 4 • Up to 6 months from date on study
|
|
General disorders
Edema
|
100.0%
2/2 • Number of events 2 • Up to 6 months from date on study
|
0.00%
0/2 • Up to 6 months from date on study
|
|
Gastrointestinal disorders
Nausea
|
50.0%
1/2 • Number of events 1 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 5 • Up to 6 months from date on study
|
|
Psychiatric disorders
Depression
|
50.0%
1/2 • Number of events 1 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 6 • Up to 6 months from date on study
|
|
General disorders
Malaise
|
100.0%
2/2 • Number of events 4 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 2 • Up to 6 months from date on study
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 3 • Up to 6 months from date on study
|
|
Reproductive system and breast disorders
Breast Pain
|
0.00%
0/2 • Up to 6 months from date on study
|
100.0%
2/2 • Number of events 2 • Up to 6 months from date on study
|
Additional Information
Victoria Soto, Project Specialist, Clinical Investigations Support Office
USC Norris Comprehensive Cancer Center
Phone: 323-226-6384
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place