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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

Primary Purpose

Uterine Cervical Neoplasms

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tc99m tilmanocept
Sponsored by
Cardinal Health 414, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uterine Cervical Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of California, San Diego
  • Sylvester Comprehensive Cancer Center
  • Wake Forest Baptist Health
  • The University of Texas M.D. Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tc99m tilmanocept

Arm Description

2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration

Outcomes

Primary Outcome Measures

Per-subject False Negative Rate
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN

Secondary Outcome Measures

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

Full Information

First Posted
July 24, 2015
Last Updated
February 7, 2019
Sponsor
Cardinal Health 414, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02509585
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Terminated
Why Stopped
low accrual
Study Start Date
January 2016 (undefined)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cardinal Health 414, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasms

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tc99m tilmanocept
Arm Type
Experimental
Arm Description
2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration
Intervention Type
Drug
Intervention Name(s)
Tc99m tilmanocept
Other Intervention Name(s)
Lymphoseek
Intervention Description
A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
Primary Outcome Measure Information:
Title
Per-subject False Negative Rate
Description
Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Per-subject Sensitivity
Description
Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node
Time Frame
1 day
Title
Per-subject Negative Predictive Value
Description
Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes
Time Frame
1 day
Title
Per-subject Accuracy
Description
Proportion of subjects accurately indentified by Lymphoseek
Time Frame
1 day
Title
Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek
Time Frame
1 day
Title
Number of Lymph Nodes Per-subject Identified by Lymphoseek
Time Frame
1 day
Title
Number of Lymph Nodes Per-subject Identified by Other Dyes
Time Frame
1 day
Title
Per-subject Concordance
Description
Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek
Time Frame
1 day
Title
Per-subject Reverse Concordance
Description
Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye
Time Frame
1 day
Title
Incidence of Adverse Events
Time Frame
7 days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Blue, MD
Organizational Affiliation
Cardinal Health 414, LLC
Official's Role
Study Director
Facility Information:
Facility Name
University of California, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Sylvester Comprehensive Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Wake Forest Baptist Health
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
The University of Texas M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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