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

moneyonomics


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
Sponsor:
Collaborator:
Norgine
Information provided by (Responsible Party):
University Hospital, Ghent

Study Description
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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
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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 related topics: Breast Cancer
Drug Information available for: Tilmanocept

Arms and Interventions
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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
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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
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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
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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
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Publications:
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

 


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