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Full eligibility criteria for NCT03029988
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
All locations for NCT03029988
United States (1)
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249
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Tris trial is registered with FDA with number: NCT03029988. The sponsor of the trial is Navidea Biopharmaceuticals and it is looking for 12 volunteers for the current phase.
Official trial title: An Exploratory Evaluation of Technetium Tc 99m Tilmanocept by Intravenous (IV) Injection in Subjects With Liver Metastases From Colorectal Carcinoma Patients Using SPECT/CT Imaging Compared to FDG PET/CT Imaging.
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