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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

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ClinicalTrials.gov Identifier: NCT02509585
Recruitment Status : Terminated (low accrual)
First Posted : July 28, 2015
Results First Posted : February 11, 2019
Last Update Posted : February 11, 2019
Sponsor:
Information provided by (Responsible Party):
Cardinal Health 414, LLC

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.

Condition or disease Intervention/treatment Phase
Uterine Cervical Neoplasms Drug: Tc99m tilmanocept Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : January 2016
Actual Primary Completion Date : July 2017
Actual Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tc99m tilmanocept
2 mCi (74 MBq), 50 ug of Tc99M tilmanocept single administration
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
Other Name: Lymphoseek




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Per-subject Accuracy [ Time Frame: 1 day ]
    Proportion of subjects accurately indentified by Lymphoseek

  4. Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek [ Time Frame: 1 day ]
  5. Number of Lymph Nodes Per-subject Identified by Lymphoseek [ Time Frame: 1 day ]
  6. Number of Lymph Nodes Per-subject Identified by Other Dyes [ Time Frame: 1 day ]
  7. Per-subject Concordance [ Time Frame: 1 day ]
    Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek

  8. 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

  9. Incidence of Adverse Events [ Time Frame: 7 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02509585


Locations
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United States, California
University of California, San Diego
La Jolla, California, United States, 92093
United States, Florida
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, North Carolina
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, Texas
The University of Texas M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Cardinal Health 414, LLC
Investigators
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Study Director: Michael Blue, MD Cardinal Health 414, LLC
  Study Documents (Full-Text)

Documents provided by Cardinal Health 414, LLC:
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Responsible Party: Cardinal Health 414, LLC
ClinicalTrials.gov Identifier: NCT02509585    
Other Study ID Numbers: NAV3-19
First Posted: July 28, 2015    Key Record Dates
Results First Posted: February 11, 2019
Last Update Posted: February 11, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases