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

February 7, 2019 updated by: Cardinal Health 414, LLC

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

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.

Study Overview

Status

Terminated

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • La Jolla, California, United States, 92093
        • University of California, San Diego
    • Florida
      • Miami, Florida, United States, 33136
        • Sylvester Comprehensive Cancer Center
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest Baptist Health
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas M.D. Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tc99m tilmanocept
2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration
A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Other Names:
  • Lymphoseek

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Per-subject False Negative Rate
Time Frame: 1 day
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
1 day

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Michael Blue, MD, Cardinal Health 414, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 24, 2015

First Submitted That Met QC Criteria

July 24, 2015

First Posted (Estimate)

July 28, 2015

Study Record Updates

Last Update Posted (Actual)

February 11, 2019

Last Update Submitted That Met QC Criteria

February 7, 2019

Last Verified

February 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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