Trial Outcomes & Findings for Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging (NCT NCT02683421)

Last Updated: 2019-11-21

Results Overview

The primary endpoint was to compare the cumulative total of anatomical zones of active RA (which were clinically defined by a swollen/tender classification during the DAS28 joint count assessment performed at baseline) with Tc 99m tilmanocept localization observed at 2-3 hours and at 4-6 hours after administration on Day 1. Tc 99m tilmanocept localization is defined by accumulation of radioactivity at an intensity greater than background, which was qualitatively determined by the central reader's visual assessment of the acquired images .

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

18 participants

Primary outcome timeframe

Swollen/tender joints assessment at baseline and Tc 99m tilmanocept localization at 2-3 hours and 4-6 hours after administration on Day 1

Results posted on

2019-11-21

Participant Flow

Participant milestones

Participant milestones
Measure	Control Subjects: 50 mcg/2 mCi Dose Healthy Volunteers: 50 mcg tilmanocept with 2 millicuries (mCi) Tc 99m Tilmanocept	Controls Subjects: 200 mcg/2mCi Dose Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 50 mcg/2 mCi Dose Rheumatoid arthritis (RA) Group: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 200 mcg/2 mCi Dose RA group:200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept
Overall Study STARTED	5	4	4	5
Overall Study COMPLETED	5	4	4	5
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of SC Injected Tc 99m Tilmanocept Localization in Active RA Subjects by SPECT and SPECT/CT Imaging

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Subjects: 50 mcg/20 mCi Dose n=5 Participants Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Control Subjects: 200 mcg/2 mCi Dose n=4 Participants Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 50 mcg/2 mCi Dose n=4 Participants RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 200 mcg/2 mCi Dose n=5 Participants RA group:200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Total n=18 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	17 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Age, Continuous	35.4 years STANDARD_DEVIATION 7.86 • n=5 Participants	32.3 years STANDARD_DEVIATION 5.74 • n=7 Participants	47 years STANDARD_DEVIATION 16.33 • n=5 Participants	56.8 years STANDARD_DEVIATION 18.54 • n=4 Participants	43.2 years STANDARD_DEVIATION 15.88 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	4 Participants n=4 Participants	11 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	5 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	18 Participants n=21 Participants

PRIMARY outcome

Timeframe: Swollen/tender joints assessment at baseline and Tc 99m tilmanocept localization at 2-3 hours and 4-6 hours after administration on Day 1

Outcome measures

Outcome measures
Measure	RA Subjects: 50 mcg/2 mCi Dose n=4 Participants RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 200 mcg/2 mCi Dose n=5 Participants RA group:200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept
Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints Total swollen/tender regions at baseline	30 Joints	35 Joints
Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints Total Tc localized regions at 2-3 hours	1 Joints	9 Joints
Localization of Tc 99m Tilmanocept by Planar and SPECT/CT Imaging in Subjects With Active RA and Concordance With Swollen/Tender Joints Total Tc localized regions at 4-6 hours	2 Joints	7 Joints

SECONDARY outcome

Timeframe: 2-4 hours and 4-6 hours

Tc 99m tilmanocept localization intensity on planar imaging was compared among dose/disease groups. Localization intensity was quantitatively analyzed by observing average voxel intensity in regions of interest, which were drawn over areas of increased uptake in the RA-affected joints.

Outcome measures

Outcome measures
Measure	Control Subjects: 50 mcg/2 mCi Dose n=5 Participants Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Control Subjects: 200 mcg/2 mCi Dose n=4 Participants Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 50 mcg/2 mCi Dose n=4 Participants RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 200 mcg/2 mCi Dose n=5 Participants RA group:200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept
Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging 2-4 Hours	0.96 Voxel Intensity Standard Deviation 0.483	0.97 Voxel Intensity Standard Deviation 0.685	1.17 Voxel Intensity Standard Deviation 0.520	1.16 Voxel Intensity Standard Deviation 0.694
Dose-dependent Tc 99m Tilmanocept Localization Intensity by Planar and SPECT/CT Imaging 4-6 Hours	0.97 Voxel Intensity Standard Deviation 0.442	1.00 Voxel Intensity Standard Deviation 0.742	1.21 Voxel Intensity Standard Deviation 0.422	1.13 Voxel Intensity Standard Deviation 0.648

SECONDARY outcome

Timeframe: 2-4 hours and 4-6 hours

Tc 99m tilmanocept localization intensity on planar imaging relative to localization intensity in corresponding background regions was calculated (percent of background) for each region of interest and averaged for each dose/disease group.

Outcome measures

Outcome measures
Measure	Control Subjects: 50 mcg/2 mCi Dose n=5 Participants Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Control Subjects: 200 mcg/2 mCi Dose n=4 Participants Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 50 mcg/2 mCi Dose n=4 Participants RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	RA Subjects: 200 mcg/2 mCi Dose n=5 Participants RA group:200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept
Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups 2-3 hours	-2.47 Percent difference from background Standard Deviation 4.471	-9.21 Percent difference from background Standard Deviation 5.178	1.59 Percent difference from background Standard Deviation 6.309	9.11 Percent difference from background Standard Deviation 25.939
Localization Intensity of Tc 99m Tilmanocept by Planar Imaging in Regions of Interest Relative to Background in All Dose Groups 4-6 hours	-1.32 Percent difference from background Standard Deviation 4.692	-6.74 Percent difference from background Standard Deviation 5.326	3.31 Percent difference from background Standard Deviation 14.544	16.34 Percent difference from background Standard Deviation 25.453

Adverse Events

Cohort 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 2

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 3

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Cohort 4

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 n=5 participants at risk Healthy Volunteers: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Cohort 2 n=4 participants at risk Healthy Volunteers: 200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Cohort 3 n=4 participants at risk RA Group: 50 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept	Cohort 4 n=5 participants at risk RA group:200 mcg tilmanocept with 2 mCi Tc 99m Tilmanocept
Investigations C-reactive protein increased	20.0% 1/5 • Number of events 1	0.00% 0/4	0.00% 0/4	0.00% 0/5
Gastrointestinal disorders Toothache	0.00% 0/5	25.0% 1/4 • Number of events 1	0.00% 0/4	0.00% 0/5
General disorders Injection site pain	0.00% 0/5	0.00% 0/4	25.0% 1/4 • Number of events 1	0.00% 0/5
Vascular disorders Hot flush	0.00% 0/5	0.00% 0/4	0.00% 0/4	20.0% 1/5 • Number of events 1
Gastrointestinal disorders Nausea	0.00% 0/5	0.00% 0/4	0.00% 0/4	20.0% 1/5 • Number of events 1

Additional Information

Bonnie C. Abbruzzese, MS, RD

Navidea Biopharmaceuticals

Phone: 614-822-2327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and make modifications to the publication.
Publication restrictions are in place

Restriction type: OTHER