Trial Outcomes & Findings for Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC) (NCT NCT01902953)

Results Overview

Number of Participants in Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

0-7 days

Results posted on

2021-06-23

Participant Flow

Participant milestones

Participant milestones
Measure	Lymphoseek and VBD SLN Dissection Ex-Vivo Lymphoseek and VBD SLN dissection Lymphoseek and VBD Sln dissection: See detailed description of study design
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lymphoseek and VBD SLN Dissection n=16 Participants Ex-Vivo Lymphoseek and VBD SLN dissection Lymphoseek and VBD Sln dissection: See detailed description of study design
Age, Continuous	63.94 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Region of Enrollment United States	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 0-7 days

Number of Participants in Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.

Outcome measures

Outcome measures
Measure	Lymphoseek and VBD SLN Dissection n=16 Participants Ex-Vivo Lymphoseek and VBD SLN dissection Lymphoseek and VBD Sln dissection: See detailed description of study design
Efficacy of Lymphoseek for Detection of Sentinel Nodes	16 Participants

SECONDARY outcome

Timeframe: On the day of surgery i.e. day 0 of index operation

Number of Participants with secondary evaluations will include localization rates (identification of any hot and/or blue node),

Outcome measures

Outcome measures
Measure	Lymphoseek and VBD SLN Dissection n=16 Participants Ex-Vivo Lymphoseek and VBD SLN dissection Lymphoseek and VBD Sln dissection: See detailed description of study design
Localization Rates	16 Participants

Adverse Events

Lymphoseek and VBD SLN Dissection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Danny Sherwinter

Maimonides

Phone: 7182837952

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place