Navidea Biopharmaceuticals, Inc.

NAVB / Message Board / Read Message

BOARD

GROUPS

Keyword
Subject

Between			and
Rec'd By

Authored By
Minimum Recs

return to message board, top of board

Msg 33397 of 33635 at 11/30/2020 8:37:52 PM by

EU LS continues progressing: recruiting starts into P4 study/comparison of Til and NC in 60 Breast Cancer patients in Gent, Belgium

Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT04487912

Recruitment Status : Recruiting

First Posted : July 27, 2020

Last Update Posted : November 24, 2020

See Contacts and Locations

Sponsor:

Collaborator:

Norgine

Information provided by (Responsible Party):

University Hospital, Ghent

Study Description

Brief Summary:

A sentinel node procedure is recommended for patients with early stages of breast cancer to exclude metastases to local lymph nodes. This procedure is done with a "tracer" which is injected near to the tumor and drains to these nearby lymph nodes. The first draining lymph node(s) are called "sentinel" node(s). These sentinel nodes are excised by the surgeon for microscopic investigation using a detection probe. This study aims to further document the distribution and dynamics of a recently approved new tracer called Tilmanocept and comparing it with the standard used tracer (nanocolloid) to determine whether there is a significant difference between both products (which are both approved for clinical use in this scenario in the European Union). This will be done by randomly assigning patients between injection of Tilmanocept or Nanocolloid and making scans on multiple (3) time points.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Sentinel Lymph Node	Drug: Tilmanocept Drug: Nanocolloid	Phase 4

Study Design

Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	60 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Diagnostic
Official Title:	Dynamics and Tracer Distribution of Tilmanocept Using Combined Subareolar and Peritumoral Injection Technique for Scintigraphic Sentinel Lymph Node Detection in Early Stage Breast Cancer
atioent	November 24, 2020
Estimated Primary Completion Date :	July 1, 2021
Estimated Study Completion Date :	September 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Breast cancer

MedlinePlus related topics: Breast Cancer

Drug Information available for: Tilmanocept

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Injection of 99m-Tc Tilmanocept	Drug: Tilmanocept Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
Active Comparator: Injection of 99m-Tc Nanocolloid	Drug: Nanocolloid Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid Other Name: Nanoscint

Outcome Measures

Primary Outcome Measures :

Time to identification of first lymph node [ Time Frame: 0-30 minutes ]
Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
Lymph node count to background ratio 4 hours post-injection [ Time Frame: 4 hours post-injection ]
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection
Lymph node count to background ratio 24 hours post-injection [ Time Frame: 20 to 24 hours post-injection ]
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection
Injection site count to background ratio 4 hours post-injection [ Time Frame: 4 hours post-injection ]
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection
Injection site count to background ratio 24 hours post-injection [ Time Frame: 20 to 24 hours post-injection ]
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Early stage breast cancer (T1, T2)
Clinically node negative (no enlarged axillary lymph nodes)

Exclusion Criteria:

Prior surgery in same breast
Pregnancy or breastfeeding

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04487912

Contacts

Contact: Robbe Waterschoot, MD	+32 9 332 30 28	Robbe.Waterschoot@uzgent.be
Contact: Ingeborg Goethals, MD PhD		Ingeborg.Goethals@uzgent.be

Locations

Belgium
university hospital, Ghent	Recruiting
Gent, Belgium
Contact: Robbe Waterschoot, Dr 093324845 ext 0032 robbe.waterschoot@uzgent.be

Sponsors and Collaborators

University Hospital, Ghent

Norgine

More Information

Publications:

Giammarile F, Alazraki N, Aarsvold JN, Audisio RA, Glass E, Grant SF, Kunikowska J, Leidenius M, Moncayo VM, Uren RF, Oyen WJ, Valdés Olmos RA, Vidal Sicart S. The EANM and SNMMI practice guideline for lymphoscintigraphy and sentinel node localization in breast cancer. Eur J Nucl Med Mol Imaging. 2013 Dec;40(12):1932-47. doi: 10.1007/s00259-013-2544-2. Epub 2013 Oct 2.

Unkart JT, Hosseini A, Wallace AM. Tc-99m tilmanocept versus Tc-99m sulfur colloid in breast cancer sentinel lymph node identification: Results from a randomized, blinded clinical trial. J Surg Oncol. 2017 Dec;116(7):819-823. doi: 10.1002/jso.24735. Epub 2017 Jul 10.

Unkart JT, Proudfoot J, Wallace AM. Outcomes of "one-day" vs "two-day" injection protocols using Tc-99m tilmanocept for sentinel lymph node biopsy in breast cancer. Breast J. 2018 Jul;24(4):526-530. doi: 10.1111/tbj.13002. Epub 2018 Mar 2.

Responsible Party:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT04487912 History of Changes
Other Study ID Numbers:	AGO/2019/003
First Posted:	July 27, 2020 Key Record Dates
Last Update Posted:	November 24, 2020
Last Verified:	June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No
Product Manufactured in and Exported from the U.S.:	No

Additional relevant MeSH terms:

Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases

e-mail to a friend

printer-friendly

add to library

| More

Recs: 7 Views: 0

return to message board, top of board

BOARDS Sign In for Filters