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

Stopped early · Phase 1

Conditions studied: Liver Metastases, Colorectal Carcinoma

In brief

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.

Key facts

Study ID

NCT03029988

Run by

Navidea Biopharmaceuticals

People needed

3

Starts

2017-07-26

Expected to finish

2018-09-24

Last updated by the study team

2020-09-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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