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

• Status: Terminated
• Trial end date: 2018-09-24
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navidea Biopharmaceuticals
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)

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