An Evaluation of Tilmanocept by IV Injection Using SPECT/CT vs PET Imaging in Subjects With Liver Metastases.
Condition: Liver Metastases; Colorectal Carcinoma
MeSH terms: Carcinoma; Neoplasm Metastasis; Liver Neoplasms; Colorectal Neoplasms
Intervention: Tilmanocept (Technetium Tc 99m tilmanocept Injection); SPECT/CT Imaging
Intervention description: Drug: Technetium Tc 99m tilmanocept; 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.
Phase: Phase 1
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.
Masking: None (Open Label)
Masking description: Open Label
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma, Colorectal Carcinoma, liver metastases

Summary:

      Estimation of the concordance of Tc 99m localization in liver metastases from colorectal
      carcinoma using SPECT/CT imaging and abdominal FDG (PET)/CT imaging per subject.
    

Eligibility criteria:

        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 Eastern Cooperative Oncology Group (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