A Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection

Uterine Cervical Neoplasms Clinical Trial

Official title:

A Prospective, Open-Label Trial of Comparing the Pathology Status of Lymphoseek®-Identified Sentinel Lymph Nodes Relative to the Pathological Pathology Status of Nonsentinel Lymph Nodes in Nodal Staging of Subjects With Known Cancer of the Cervix Who Are Undergoing Lymph Node Dissection

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02509585
• Other study ID #: NAV3-19
• Status: Terminated
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: July 2017

Study information

• Verified date: February 2019
• Source: Cardinal Health 414, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, open-label, within-patient, multi-center study of Lymphoseek in the detection of lymph nodes in subjects with known cancer of the cervix. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 18
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has provided written informed consent with HIPAA authorization

• Has cervical cancer and is a candidate for surgical intervention, with lymph node dissection being a part of the surgical plan.

• Is at least 18 years of age at the time of consent

• Has an ECOG performance status of Grade 0 to 2

• Has the following International Federation of Gynecology and Obstetrics (FIGO) IA2-IIA1staging. Subjects with a single enlarged/suspicious node on PET/CT will still be considered eligible as consistent with FIGO guidelines.

• If of childbearing potential, the subject has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year

Exclusion Criteria:

• The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 30 days prior to Lymphoseek administration

• Has had previous surgery or radiation to node basins that would be involved in the ILM procedure

• Has a known allergy to dextran

• Is breast-feeding or pregnant

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

• Is scheduled for surgery and/or another invasive procedure other than the primary surgical intervention within the 3 days after Lymphoseek administration

• Has received an investigational product within the 30 days prior to Lymphoseek administration

Related Conditions & MeSH terms

• Uterine Cervical Neoplasms

Intervention

Drug:
• Tc99m tilmanocept
A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery

Locations

Country	Name	City	State
United States	The University of Texas M.D. Anderson Cancer Center	Houston	Texas
United States	University of California, San Diego	La Jolla	California
United States	Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

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	Per-subject False Negative Rate	Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN	1 day
Secondary	Per-subject Sensitivity	Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node	1 day
Secondary	Per-subject Negative Predictive Value	Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes	1 day
Secondary	Per-subject Accuracy	Proportion of subjects accurately indentified by Lymphoseek	1 day
Secondary	Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek		1 day
Secondary	Number of Lymph Nodes Per-subject Identified by Lymphoseek		1 day
Secondary	Number of Lymph Nodes Per-subject Identified by Other Dyes		1 day
Secondary	Per-subject Concordance	Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek	1 day
Secondary	Per-subject Reverse Concordance	Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye	1 day
Secondary	Incidence of Adverse Events		7 days