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

Study Overview
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Brief Summary
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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.

Detailed Description
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This is a prospective, open-label, single-center, comparator study of IV injected Tc 99m Tilmanocept in the localization and detection of liver metastases in subjects with confirmed colorectal carcinoma (CRC). The study will be divided into two cohorts. If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data. This study is designed to evaluate the safety and tolerability of Tc 99m tilmanocept administered intravenously. SPECT/CT imaging of the subject's abdominal cavity will be reviewed to establish concordance with FDG PET imaging.

Official Title
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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 Fluorodeoxyglucose (FDG) PET/CT Imaging.

Conditions
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Liver Metastases, Colorectal Carcinoma

Intervention / Treatment
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* Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)
* Procedure: SPECT/CT Imaging


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection. | Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)<br>* Drug: Technetium Tc 99m tilmanocept<br>* Other names: Lymphoseek;Procedure: SPECT/CT Imaging<br>* 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.<br>|
| Experimental: Cohort 2<br>Subjects will receive 200 µg tilmanocept radiolabeled with 2.0 mCi Tc99m through a single IV injection. If it was determined that additional enrollment would not provide meaningful data, for example no metastatic liver lesions were visualized by Tc 99m tilmanocept for any of the subjects in the cohort, enrollment into Cohort 2 would begin and 3 subjects would be enrolled followed by a review of the imaging and safety data. | Drug: Tilmanocept (Technetium Tc 99m tilmanocept Injection)<br>* Drug: Technetium Tc 99m tilmanocept<br>* Other names: Lymphoseek;Procedure: SPECT/CT Imaging<br>* 4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visualization of Lesions by FDG PET/CT Imaging and by Tc 99m Tilmanocept SPECT/CT Imaging. | The primary objectives of this study were to estimate the concordance of Tc 99m tilmanocept localization in liver metastases from colorectal carcinoma (CRC) using single photon emission computed tomography / computed tomography (SPECT/CT) imaging and abdominal fluorodeoxyglucose positron emission tomography-computed tomography (FDG PET/CT) imaging per subject and to evaluate the safety including monitoring the incidence of adverse events and changes over time in laboratory tests, vital signs, and physical examination findings. | Within 7 days after Tc 99m tilmanocept administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma, Colorectal Carcinoma, liver metastases