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

NCT03029988 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: NAV3-251R44CA162783-01
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Metastases; Colorectal Carcinoma

Keywords

adenocarcinoma, Colorectal Carcinoma, liver metastases

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Cohort 1

EXPERIMENTAL

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); Procedure: SPECT/CT Imaging

Cohort 2

EXPERIMENTAL

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); Procedure: SPECT/CT Imaging

Interventions

Tilmanocept (Technetium Tc 99m tilmanocept Injection) DRUG

Drug: Technetium Tc 99m tilmanocept

Also known as: Lymphoseek

Cohort 1; Cohort 2

SPECT/CT Imaging PROCEDURE

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

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Navidea Biopharmaceuticals: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Alabama Birmingham

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Adenocarcinoma

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Limitations and Caveats

Early termination leading to small number of subjects.

Results Point of Contact

• Title: Bonnie Abbruzzese Senior Director
• Organization: Navidea Biopharmaceuticals

babbruzzese@navidea.com

614.793.7500

Study Officials

• Frederick O Cope, PhD

  Navidea Biopharmaceuticals

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Injection and imaging will begin with Cohort 1. Cohort 1 and Cohort 2 will receive tilmanocept intravenously.

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 24, 2017
• Study Start: July 26, 2017
• Primary Completion: September 24, 2018
• Study Completion: September 24, 2018
• Last Updated: September 10, 2020
• Results First Posted: November 18, 2019

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)