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

NCT ID: NCT03029988

Last Updated: 2020-09-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-26
• Study Completion Date: 2018-09-24

Brief 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.

Detailed Description

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.

Conditions

Liver Metastases; Colorectal Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1

Subjects will receive 50 µg tilmanocept radiolabeled with 2.0 millicuries (mCi) Tc99m through a single IV injection.

Group Type: EXPERIMENTAL

Tilmanocept (Technetium Tc 99m tilmanocept Injection)

Intervention Type: DRUG

Drug: Technetium Tc 99m tilmanocept

SPECT/CT Imaging

Intervention Type: PROCEDURE

4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.

Cohort 2

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.

Group Type: EXPERIMENTAL

Tilmanocept (Technetium Tc 99m tilmanocept Injection)

Intervention Type: DRUG

Drug: Technetium Tc 99m tilmanocept

SPECT/CT Imaging

Intervention Type: PROCEDURE

4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.

Interventions

Tilmanocept (Technetium Tc 99m tilmanocept Injection)

Drug: Technetium Tc 99m tilmanocept

Intervention Type: DRUG

SPECT/CT Imaging

4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.

Intervention Type: PROCEDURE

Other Intervention Names

Lymphoseek

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Navidea Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick O Cope, PhD

Role: PRINCIPAL_INVESTIGATOR

Navidea Biopharmaceuticals

Locations

University of Alabama Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1R44CA162783-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NAV3-25

Identifier Type: -

Identifier Source: org_study_id