TheranosticTrials.org

Clinical Trial · NCT03029988

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

Overview

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.

Sponsor

Avid Radiopharmaceuticals

Phase

Phase 1

Contacts

Frederick O Cope, PhD (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT03029988

Drug / Compound

FDG

Isotope(s):
Target(s):
  • Glucose Transport
Ligand Class: Small Molecules

Tilmanocept

Isotope(s):
Target(s):
  • Mannose Receptor (CD206/MRC1)
Ligand Class: Small Molecules

Tilmanocept

Isotope(s):
Target(s):
  • Mannose Receptor (CD206/MRC1)
Ligand Class: Small Molecules

Eligibility

Inclusion

  • * The subject has provided written informed consent with Health Information Portability and Accountability Act (HIPAA) authorization before the initiation of any study-related procedures.
  • The subject must have a diagnosis of adenocarcinoma of the colon and/or rectum with FDG PET/CT confirmed metastases to the liver;
  • The subject must be at least 4 weeks past any major intraabdominal surgery, including surgery to the liver;
  • The subjects must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3;
  • Subjects must be ≥18 years old;

Exclusion

  • The subject has known sensitivity to dextran.
  • Before the administration of Tc 99m Tilmanocept, has received any radiopharmaceutical within 7 radioactive half-lives of that radiopharmaceutical
  • The subject has had preoperative chemotherapy, immunotherapy, or radiation therapy within the 10 days prior to Tc 99m Tilmanocept administration
  • * The subject is pregnant or lactating.
  • The subject has undergone any liver surgery, exclusive of a biopsy.