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
Status: | Terminated |
---|---|
Conditions: | Cervical Cancer, Women's Studies |
Therapuetic Areas: | Oncology, Reproductive |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 2/13/2019 |
Start Date: | January 2016 |
End Date: | July 2017 |
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.
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.
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
We found this trial at
4
sites
1515 Holcombe Blvd
Houston, Texas 77030
Houston, Texas 77030
713-792-2121
Principal Investigator: Michael Frumovitz, MD, MPH
Phone: 713-794-5556
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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9500 Gilman Dr
La Jolla, California 92093
La Jolla, California 92093
(858) 534-2230
Principal Investigator: McHale Michael, MD
Phone: 858-822-5398
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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Miami, Florida 33136
Principal Investigator: Matthew Pearson
Phone: 305-243-8194
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Winston-Salem, North Carolina 27157
Principal Investigator: Samuel Lentz, MD
Phone: 336-716-9428
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