An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.

This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m
Tilmanocept in the localization and detection of liver metastases in subjects with confirmed
CRC. The study will be divided into two cohorts.

This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept
administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be
reviewed to establish concordance with FDG PET imaging.

Inclusion Criteria:

- The subject has provided written informed consent with Health Information Portability
and Accountability Act (HIPAA) authorization before the initiation of any
study-related procedures.

- Subjects must be ≥18 years old;

- The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with
FDG PET/CT confirmed metastases to the liver;

- The subjects must have an ECOG performance status of 0-3;

- The subject must be at least 4 weeks past any major intraabdominal surgery, including
surgery to the liver;

- Subjects with prior malignancies other than colon and/or rectum cancer are allowed,
provided they have been treated with curative intent, and have no evidence of
recurrence of that malignancy;

- Each subject must have no more than 10 qualifying liver lesions that have been
clinically confirmed metastatic adenocarcinoma of the colon by FDG PET/CT imaging.

- If of childbearing potential, the subject has a negative urine pregnancy test within
48 hours before administration of Tc 99m Tilmanocept, has been surgically sterilized,
or has been postmenopausal for at least 1 year

Exclusion Criteria:

- The subject is pregnant or lactating.

- The subject has undergone any liver surgery, exclusive of a biopsy.

- The subject has known sensitivity to dextran.

- The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy
within the 10 days prior to Tc 99m Tilmanocept administration

- Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical
within 7 radioactive half-lives of that radiopharmaceutical

- Has received an investigational product within the 30 days prior to Tc 99m Tilmanocept
administration