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
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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Uterine Cervical Neoplasms
Lead sponsor: Cardinal Health 414, LLC
Sponsor class: INDUSTRY
First posted: 2015-07-28
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


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

Primary outcomes:
measure: Per-subject False Negative Rate
timeFrame: 1 day
Secondary outcomes:
measure: Per-subject Sensitivity
timeFrame: 1 day
measure: Per-subject Negative Predictive Value
timeFrame: 1 day
measure: Per-subject Accuracy
timeFrame: 1 day
measure: Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek
timeFrame: 1 day
measure: Number of Lymph Nodes Per-subject Identified by Lymphoseek
timeFrame: 1 day
measure: Number of Lymph Nodes Per-subject Identified by Other Dyes
timeFrame: 1 day
measure: Per-subject Concordance
timeFrame: 1 day
measure: Per-subject Reverse Concordance
timeFrame: 1 day
measure: Incidence of Adverse Events
timeFrame: 7 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Houston
country: United States
facility: The University of Texas M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: Cardinal Health 414, LLC
name: Michael Blue, MD
role: STUDY_DIRECTOR
References: