NCT02509585

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 28, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

February 11, 2019

Completed
Last Updated

February 11, 2019

Status Verified

February 1, 2019

Enrollment Period

1.5 years

First QC Date

July 24, 2015

Results QC Date

January 16, 2019

Last Update Submit

February 7, 2019

Conditions

Uterine Cervical Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Per-subject False Negative Rate

    Proportion of subjects with pathologically negative Lymphoseek-identified SLNs and at least one pathologically positive non-SLN

    1 day

Secondary Outcomes (9)

  • Per-subject Sensitivity

    1 day

  • Per-subject Negative Predictive Value

    1 day

  • Per-subject Accuracy

    1 day

  • Proportion of Lymph Nodes Identified Intraoperatively by a Dye That Are Also Identified by Lymphoseek

    1 day

  • Number of Lymph Nodes Per-subject Identified by Lymphoseek

    1 day

  • +4 more secondary outcomes

Study Arms (1)

Tc99m tilmanocept

EXPERIMENTAL

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

Drug: Tc99m tilmanocept

Interventions

Tc99m tilmanoceptDRUG

A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery

Also known as: Lymphoseek
Tc99m tilmanocept

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

The University of Texas M.D. Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Results Point of Contact

Title
LaTosha Eligon
Organization
Cardinal Health
latosha.eligon@cardinalhealth.com
913-661-3896

Study Officials

  • Michael Blue, MD

    Cardinal Health 414, LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2015

First Posted

July 28, 2015

Study Start

January 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 11, 2019

Results First Posted

February 11, 2019

Record last verified: 2019-02

Locations

US(4)