Trial Outcomes & Findings for SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer (NCT NCT03294330)

Last Updated: 2023-01-12

Results Overview

The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

35 participants

Primary outcome timeframe

Intraoperative, up to 1 hour

Results posted on

2023-01-12

Participant Flow

Subjects recruited in surgical clinic between 10/11/2017 - 9/13/2021

One subject withdrew due to change in OR location and lack of SPY machine. No other relevant events.

Participant milestones

Participant milestones
Measure	Patients With Melanoma or Breast Cancer The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy. IC-Green KIT: fluorescence lymphangiography with the use of IC-Green
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

SPY-X: A Study to Assess the Feasibility of Using SPY Alone for Sentinel Node Localization for Melanoma or Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With Melanoma or Breast Cancer n=35 Participants The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy. IC-Green KIT: fluorescence lymphangiography with the use of IC-Green
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	18 Participants n=5 Participants
Age, Continuous	64.5 years n=5 Participants
Sex: Female, Male Female	18 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	35 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
BMI	27.3 kg/m^2 n=5 Participants
Tumor location Upper extremity	21 Participants n=5 Participants
Tumor location Lower extremity	14 Participants n=5 Participants

PRIMARY outcome

Timeframe: Intraoperative, up to 1 hour

Population: Patients with cutaneous melanoma of the extremity.

Outcome measures

Outcome measures
Measure	Patients With Melanoma or Breast Cancer n=35 Participants The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy. IC-Green KIT: fluorescence lymphangiography with the use of IC-Green
Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone First sentinel node	29 Participants
Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone Second sentinel node	9 Participants
Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone Third sentinel node	0 Participants

SECONDARY outcome

Timeframe: Four weeks

Population: Patients with cutaneous melanoma of extremity who had a sentinel node biopsy

Any adverse events related to ICG or sentinel node biopsy.

Outcome measures

Outcome measures
Measure	Patients With Melanoma or Breast Cancer n=35 Participants The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy. IC-Green KIT: fluorescence lymphangiography with the use of IC-Green
Adverse Events	7 participants

Adverse Events

Patients With Melanoma or Breast Cancer

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients With Melanoma or Breast Cancer n=35 participants at risk The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy. IC-Green KIT: fluorescence lymphangiography with the use of IC-Green
Skin and subcutaneous tissue disorders seroma	8.6% 3/35 • Number of events 3 • One month after surgery. Adverse events were collected intraop, postop and at the time of follow-up visit between 2-4 weeks after surgery.
Skin and subcutaneous tissue disorders hematoma	5.7% 2/35 • Number of events 2 • One month after surgery. Adverse events were collected intraop, postop and at the time of follow-up visit between 2-4 weeks after surgery.
Skin and subcutaneous tissue disorders SSI	2.9% 1/35 • Number of events 1 • One month after surgery. Adverse events were collected intraop, postop and at the time of follow-up visit between 2-4 weeks after surgery.
Skin and subcutaneous tissue disorders rash	2.9% 1/35 • Number of events 1 • One month after surgery. Adverse events were collected intraop, postop and at the time of follow-up visit between 2-4 weeks after surgery.

Additional Information

Colette Pameijer

Penn State College of Medicine

Phone: 717-531-5272

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place