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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Anal Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Lymphoseek - 0.5 mCi, 50 ug

A single dose of 50 µg Lymphoseek radiolabeled with 0.5 millicurie (mCi) (18.5 MBq) 99m Tc

Group Type EXPERIMENTAL

Lymphoseek

Intervention Type DRUG

Interventions

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Lymphoseek

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No