Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer
Primary Purpose
Breast Cancer, Sentinel Lymph Node
Status
Withdrawn
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
Tilmanocept
Nanocolloid
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer
Eligibility 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
Sites / Locations
- university hospital, Ghent
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Injection of 99m-Tc Tilmanocept
Injection of 99m-Tc Nanocolloid
Arm Description
Outcomes
Primary Outcome Measures
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
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
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
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04487912
First Posted
July 22, 2020
Last Updated
May 12, 2021
Sponsor
University Hospital, Ghent
Collaborators
Norgine
1. Study Identification
Unique Protocol Identification Number
NCT04487912
Brief Title
Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient patient inclusion
Study Start Date
November 24, 2020 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
Norgine
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Sentinel Lymph Node
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection of 99m-Tc Tilmanocept
Arm Type
Active Comparator
Arm Title
Injection of 99m-Tc Nanocolloid
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Tilmanocept
Intervention Description
Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
Intervention Type
Drug
Intervention Name(s)
Nanocolloid
Other Intervention Name(s)
Nanoscint
Intervention Description
Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid
Primary Outcome Measure Information:
Title
Time to identification of first lymph node
Description
Time to identification of first lymph node on the dynamic acquisition during the first 30 minutes post-injection
Time Frame
0-30 minutes
Title
Lymph node count to background ratio 4 hours post-injection
Description
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 4 hours post-injection
Time Frame
4 hours post-injection
Title
Lymph node count to background ratio 24 hours post-injection
Description
Number of identified lymph nodes and count-to-background ratio in these identified lymph nodes obtained by SPECT/CT 24 hours post-injection
Time Frame
20 to 24 hours post-injection
Title
Injection site count to background ratio 4 hours post-injection
Description
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 4 hours post-injection
Time Frame
4 hours post-injection
Title
Injection site count to background ratio 24 hours post-injection
Description
Count-to-background ratio in the radionuclide injection sites obtained by SPECT/CT 24 hours post-injection
Time Frame
20 to 24 hours post-injection
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
university hospital, Ghent
City
Gent
Country
Belgium
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24085499
Citation
Giammarile F, Alazraki N, Aarsvold JN, Audisio RA, Glass E, Grant SF, Kunikowska J, Leidenius M, Moncayo VM, Uren RF, Oyen WJ, Valdes 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.
Results Reference
background
PubMed Identifier
28695567
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.
Results Reference
background
PubMed Identifier
29498443
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.
Results Reference
background
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Dynamics and Tracer Distribution of Tilmanocept in Early Stage Breast Cancer
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