Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

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

Tc99m tilmanocept

Michael Blue, MD

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.

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

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

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

Proportion of subjects with at least one pathologically positive Lymphoseek-identified SLN that have at least one pathologically positive lymph node

Proportion of subjects with pathologically negative Lymphoseek-identified SLN(s) with no pathologically positive lymph nodes

Proportion of subjects accurately indentified by Lymphoseek

Subjects whose lymph nodes were determined to be dye positive that were also identified by Lymphoseek

Number of subjects whose lymph nodes that were identified by Lymphoseek were also all identified by dye

Cardinal Health 414, LLC

Enrolled subjects who were administered any injection of Tc99m tilmanocept.

Tc99m Tilmanocept

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Grade 0: Fully active (better outcome) Grade 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature Grade 2: Ambulatory and capable of all self-care but unable to carry out any work activities Grade 3: Capable of only limited self-care Grade 4: Completely disabled. Cannot carry on any self-care. Grade 5: Dead (worse outcome)

ECOG Status

LaTosha Eligon

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

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

Intent-To-Treat

Participants receiving a single dose of 50 µg Lymphoseek radiolabeled with 2 mCi (74 MBq) Tc 99m for whom at least one lymph node was removed with histopathology available

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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