Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04487912
• Other study ID #: AGO/2019/003
• Status: Withdrawn
• Phase: Phase 4
• Start date: November 24, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2020
• Source: University Hospital, Ghent
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Sentinel Lymph Node

Intervention

Drug:
• Tilmanocept
Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
• Nanocolloid
Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid

Locations

Country	Name	City	State
Belgium	university hospital, Ghent	Gent

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Ghent	Norgine

Country where clinical trial is conducted

Belgium, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to identification of first lymph node	Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection	0-30 minutes
Primary	Lymph node count to background ratio 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	4 hours post-injection
Primary	Lymph node count to background ratio 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	20 to 24 hours post-injection
Primary	Injection site count to background ratio 4 hours post-injection	Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection	4 hours post-injection
Primary	Injection site count to background ratio 24 hours post-injection	Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection	20 to 24 hours post-injection