- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02509585
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
Conditions
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:
|
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.
Sponsor
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
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NAV3-19
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.
Clinical Trials on Uterine Cervical Neoplasms
-
Huazhong University of Science and TechnologyUnknownCervical Cancer | Uterine Cervical Cancer | Uterine Cervical NeoplasmChina
-
Huazhong University of Science and TechnologyChongqing University Cancer Hospital; Peking University People's Hospital; Qilu... and other collaboratorsRecruitingCervical Cancer | Uterine Cervical Cancer | Uterine Cervical NeoplasmChina
-
Huazhong University of Science and TechnologyQilu Hospital of Shandong University; Third Military Medical University; Women... and other collaboratorsRecruitingCervical Cancer | Uterine Cervical Cancer | Uterine Cervical NeoplasmChina
-
University of AarhusRecruitingUterine Cervical Neoplasm | Mass Screening | Uterine Cervical Disease | Uterine NeoplasmDenmark
-
Siriwan Tangjitgamol, MDPrince of Songkla University; National Research Council of Thailand; Chiang Mai... and other collaboratorsUnknownUterine Cervical CancerThailand
-
Tampere UniversityGlaxoSmithKline; FinnMedi OyEnrolling by invitation
-
Huazhong University of Science and TechnologyZhejiang University; Wuhan Central HospitalUnknownCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerChina
-
Washington University School of MedicineTerminatedCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerUnited States
-
Huazhong University of Science and TechnologyShandong University; Zhejiang UniversityCompletedCervical Cancer | Uterine Cervical Neoplasms | Uterine Cervical CancerChina
-
Center Eugene MarquisCompleted
Clinical Trials on Tc99m tilmanocept
-
Navidea BiopharmaceuticalsRecruitingRheumatoid ArthritisUnited States
-
Navidea BiopharmaceuticalsActive, not recruitingRheumatoid ArthritisUnited States
-
Navidea BiopharmaceuticalsNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedHIV Infections | Kaposi SarcomaUnited States
-
Cardinal Health 414, LLCCompleted
-
Navidea BiopharmaceuticalsCompletedNonalcoholic Steatohepatitis | NASH - Nonalcoholic SteatohepatitisUnited States
-
UMC UtrechtRecruitingEndometrial CancerNetherlands
-
Navidea BiopharmaceuticalsWithdrawn
-
Navidea BiopharmaceuticalsCompletedRheumatoid ArthritisUnited States
-
University Hospital, GhentNorgineWithdrawnBreast Cancer | Sentinel Lymph NodeBelgium
-
University of California, San DiegoRecruiting