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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02509598
Other study ID # NAV3-18
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date August 2015
Est. completion date March 6, 2019

Study information

Verified date March 2020
Source Cardinal Health 414, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Open label, non-randomized, multi-center, within-subject comparative study to evaluate the tolerability and the diagnostic utility of Lymphoseek with optional comparison to VBD in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumor. Subject age will range from neonatal through 17 years.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date March 6, 2019
Est. primary completion date March 6, 2019
Accepts healthy volunteers No
Gender All
Age group N/A to 17 Years
Eligibility Inclusion Criteria:

- The subject's parent(s)/legal guardian(s) understand(s) and voluntarily signed an informed consent document prior to any study-related assessments/procedures being conducted. Where locally applicable, the subject also understands and voluntarily provides his/her assent prior to any study-related assessments/procedures being conducted

- Subject has been diagnosed with melanoma, rhabdomyosarcoma, or other tumor where tumor resection or biopsy is planned and lymph node mapping is appropriate

- The subject is clinically node negative (cN0) at the time of screening

- Age < 18 years

- Male subjects of childbearing potential must be willing to use a condom during sexual intercourse and shall not father a child during the course of the study or will practice complete abstinence while on study

- Female subjects of childbearing potential must agree to the use of two physician-approved contraceptive methods simultaneously or practice complete abstinence while on study

Exclusion Criteria:

- The subject has had preoperative radiation therapy

- Has had previous surgery or radiation to node basins that would be involved in the intraoperative lymph node mapping (ILM) procedure

- Has a known allergy to dextran or VBD (if intended to be used)

- Has a history of alcohol abuse or alcohol dependency in the 3 years before study entry, or is an alcoholic or drug addict, as determined by the investigator

- Before the administration of Lymphoseek, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tc99m tilmanocept
A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery
Vital Blue Dye (optional)
A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).
Procedure:
Lymph Node Mapping
Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection

Locations

Country Name City State
United States Children's Hospital Medical Center Cincinnati Ohio
United States Nationwide Children's Hospital Columbus Ohio
United States The University of Texas MD Anderson Cancer Center Houston Texas
United States Nemours Children's Specialty Care Jacksonville Florida
United States Nemours Children's Hopsital Orlando Florida
United States Children's Hospital of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Cardinal Health 414, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of adverse events in pediatric subjects with melanoma, rhabdomyosarcoma, or other solid tumors who are undergoing lymph node mapping Evaluation of safety and tolerability of Lymphoseek 14 Days
Secondary Changes in vital signs Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each vital sign parameter by time point, for each tumor type and overall. 14 Days
Secondary Changes in laboratory parameters Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each quantitative laboratory parameter by time point, for each tumor type and overall. 14 Days
Secondary Changes in ECG parameters Summary statistics (mean, median, sample size, standard deviation, minimum, and maximum) will be computed on the raw and change from baseline values for each ECG parameter by time point, for each tumor type and overall. 14 Days
Secondary Number of lymph nodes identified preoperatively using SPECT or SPECT/CT 1 Day
Secondary Proportion of subjects who underwent preoperative SPECT or SPECT/CT and proportion of subjects with a lymph node identified preoperatively using SPECT or SPECT/CT 1 Day
Secondary Agreement of the number of nodes identified by preoperative SPECT or SPECT/CT to intraoperative localization 1 Day
Secondary Subject and nodal agreement of central pathology assessment with local pathology assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases 1 Day
Secondary Number of changes in postsurgical treatment plan in relation to nodes identified by Lymphoseek Changes to postsurgical treatment plan will be compared to baseline treatment plan. 1 Day
Secondary Number of lymph nodes identified intraoperatively per subject 1 Day
Secondary Nodal false negative rate for nodes identified The number of pathology-positive lymph nodes that were missed intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. 1 Day
Secondary Nodal sensitivity The number of pathology-positive lymph nodes that were identified intraoperatively by mapping agent divided by the total number of pathology-positive lymph nodes for that mapping agent. 1 Day
Secondary Upstaging The proportion of patients with pathology-positive lymph nodes who had at least one pathology-positive lymph node that was identified by Lymphoseek and had no other pathology-positive lymph nodes (i.e., identified by any other method) 1 Day
Secondary Change in subject nodal staging before and after surgery based upon nodes identified 1 Day
Secondary Subject localization rates The proportion of subjects with Lymphoseek-identified lymph nodes 1 Day
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