Kaposi's Sarcoma
Conditions
Brief summary
The purpose of this study (NAV3-12) is to determine the dissemination and localization of Tc 99m tilmanocept by SPECT and SPECT/CT imaging in subjects with confirmed cutaneous KS. This is a single center, open-label, within-subject study.
Interventions
Sponsors
Navidea Biopharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. The subject has provided written informed consent with Health Insurance Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures. 2. The subject is at least 18 years of age at the time of consent. 3. The subject has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 2. 4. The subject has a KS stage of T(0), I(0), S(0). 5. The subject has a marker lesion with a confirmed diagnosis of KS (CD 206-expressing cutaneous KS) via punch biopsy. The location of the marker KS lesion will be limited to locations on the extremities: from the shoulder to the metacarpal region or from the groin to the metatarsal region. 6. The subject has a marker KS lesion that is ≥ 1cm in diameter.
Exclusion criteria
1. The subject is pregnant or lactating. 2. The subject has had prior chemotherapy, immunotherapy, or radiation therapy to the local KS site or regional lymphatic system within one year of enrollment. 3. The subject has undergone node basin surgery of any type or radiation to the nodal basin(s) potentially draining the marker KS lesion. 4. The subject has known sensitivity to dextran.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Localization | Up to 4 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Localization | 1 hour | Number of Participants with Localization at One Hour |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 5 |
| Total | 5 |
Baseline characteristics
| Characteristic | Tc 99m Tilmanocept |
|---|---|
| Age, Continuous | 47.5 years STANDARD_DEVIATION 9.8 |
| HIV Diagnosis HIV- | 1 participants |
| HIV Diagnosis HIV+ | 4 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 5 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 5 |
| serious Total, serious adverse events | 0 / 5 |
Outcome results
Primary
Localization
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.
Time frame: Up to 4 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tc 99m Tilmanocept | Localization | 5 participants |
Secondary
Time to Localization
Number of Participants with Localization at One Hour
Time frame: 1 hour
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tc 99m Tilmanocept | Time to Localization | 5 participants localizing in 1 hour |