Anal Cancer
Conditions
Brief 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.
Detailed 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.
Interventions
DRUGLymphoseek
Sponsors
Cardinal Health 414, LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
| Incidence of Adverse Events | 5 Days |
Outcome results
None listed