Trial Outcomes & Findings for Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT (NCT NCT02201420)

NCT ID: NCT02201420

Last Updated: 2016-09-27

Results Overview

Count of subjects with a localization by Tc 99m tilmanocept by imaging. Localization is based on the use of SPECT imaging and defined as the accumulation of radioactivity at intensity greater than background.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

5 participants

Primary outcome timeframe

Up to 4 days

Results posted on

2016-09-27

Participant Flow

Participant milestones

Participant milestones
Measure	Tc 99m Tilmanocept Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging. Tc 99m tilmanocept
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Tc 99m Tilmanocept Localization in Primary Cutaneous Kaposi's Sarcoma and Lymphatic Drainage by SPECT/CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tc 99m Tilmanocept n=5 Participants Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging. Tc 99m tilmanocept
Age, Continuous	47.5 years STANDARD_DEVIATION 9.8 • n=93 Participants
Sex: Female, Male Female	0 Participants n=93 Participants
Sex: Female, Male Male	5 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	4 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	5 participants n=93 Participants
HIV Diagnosis HIV+	4 participants n=93 Participants
HIV Diagnosis HIV-	1 participants n=93 Participants

PRIMARY outcome

Timeframe: Up to 4 days

Outcome measures

Outcome measures
Measure	Tc 99m Tilmanocept n=5 Participants Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging. Tc 99m tilmanocept
Localization	5 participants

SECONDARY outcome

Timeframe: 1 hour

Number of Participants with Localization at One Hour

Outcome measures

Outcome measures
Measure	Tc 99m Tilmanocept n=5 Participants Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging. Tc 99m tilmanocept
Time to Localization	5 participants localizing in 1 hour

Adverse Events

Tc 99m Tilmanocept

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tc 99m Tilmanocept n=5 participants at risk Subjects who are enrolled and will receive 50 micrograms tilmanocept radiolabeled with 2 millicuries of Tc 99m and undergo serial SPECT or SPECT/CT imaging. Tc 99m tilmanocept
Gastrointestinal disorders Nausea	20.0% 1/5 • Number of events 1
General disorders Fatigue	20.0% 1/5 • Number of events 1
General disorders Leg Edema	20.0% 1/5 • Number of events 1

Additional Information

Dr. Frederick O. Cope, Chief Scientific Officer

Navidea Biopharmaceuticals, Inc.

Phone: 614-793-7500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The PI shall not submit a publication to journals or professional societies without the prior written approval of the Sponsor.
Publication restrictions are in place

Restriction type: OTHER