A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus

Anal Cancer Clinical Trial

Official title:

A Prospective, Open-Label, Multi-center Comparison of Lymphoseek Identified Lymph Nodes and Clinically Identified Lymph Nodes of Subjects With Known Cancer of the Anus

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02857608
• Other study ID #: NAV3-20
• Status: Withdrawn
• Phase: Phase 2
• First received: August 2, 2016
• Last updated: March 13, 2017
• Start date: September 2016
• Est. completion date: August 2017

Study information

• Verified date: March 2017
• Source: Cardinal Health 414, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus.

Description:

Prospective, open-label, within-subject, multi-center pilot study of Lymphoseek in the detection of lymph nodes in subjects with known squamous cell carcinoma of the anus. All subjects will receive a single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99mTc.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Subject has provided written informed consent with Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization

• Has histologically confirmed squamous cell carcinoma of the anus (anal canal or perianus)

• Has a documented clinical stage using the tumor, lymph node, metastasis staging (TNM) classification system that was established by at least physical exam with manual palpation, digital anorectal examination, high-resolution anoscopy and PET/CT imaging evaluation of the bilateral inguinal area

• Is at least 18 years of age at the time of consent

• Has an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0 to 3

• 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 radiation therapy, chemotherapy or immunotherapy within the 30 days prior to Lymphoseek administration

• Has had previous surgery or node dissection (exclusive of fine needle aspiration) or radiation to node basins that would be involved in the intraoperative lymphatic mapping 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

• Has received an investigational product within the 30 days prior to Lymphoseek administration

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms

Intervention

Drug:
• Lymphoseek

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cardinal Health 414, LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by standard of care methods)		2-5 Days
Secondary	Reverse Concordance (the proportion of the number of subjects with lymph nodes identified by Lymphoseek and standard of care methods compared to the number of subjects with lymph nodes identified by Lymphoseek)		2-5 Days
Secondary	Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by standard of care methods)		2-5 Days
Secondary	Reverse Nodal Concordance (the proportion of the number lymph nodes identified by Lymphoseek and standard of care methods compared to the number of lymph nodes identified by Lymphoseek)		2-5 Days
Secondary	Incidence of Adverse Events		5 Days