Tilmanocept vs Sulfur Colloid in Sentinel Lymph Node Biopsy

August 23, 2018 updated by: Memorial Health University Medical Center

A Randomized Controlled Double-blinded Study Comparing the Intraoperative Injection of Lymphatic Mapping Agents Tc 99m Tilmanocept to Tc 99m Filtered Sulfur Colloid in Breast Cancer Patients Undergoing Breast Conservation and Sentinel Lymph Node Biopsy

A randomized controlled double-blinded study comparing the intraoperative injection of lymphatic mapping agents Tc 99m tilmanocept to Tc 99m filtered sulfur colloid in breast cancer patients undergoing breast conservation and sentinel lymph node biopsy

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a double-blinded randomized control trial comparing tilmanocept to TSC as intraoperative radiolabeled mapping agents in female patients with early stage breast cancer undergoing partial mastectomy with SLNBx.

To secure this aim, patients who are schedule to undergo partial mastectomy and SLBx will be consented and randomized (randomization table) into one of two experimental arms, tilmanocept or TSC.

These patients will then undergo their scheduled partial mastectomy with SLNBx, with the patient and surgeon blinded to the randomization result.

The respective radiotracers will both be delivered to the OR in the same delivery device and volumes to continue to preserve anonymity of the material. Care will be taken to handle the radiotracers along the standards and guidelines that are already in practice in Memorial Health University Hospital's nuclear medicine department. Two intradermal injections of these radiotracers will be delivered at 3 and 6 o'clock positions at the edge of the areola, after induction of general anesthesia, allowing for less discomfort to the patient.

Methylene blue (5-10 ml) will also be injected in the subareolar space immediately afterwards in all study patients, using a separate syringe, in accordance with the surgeon's current standard practice.

Transcutaneous probing of the axilla measuring counts per second will be performed in 3 minute intervals after injection of the radiotracer. Incision in the axilla can, at the earliest, be at 15 minutes, as this is the FDA approved earliest time for tilmanocept. At this time, if the transcutaneous "hot spot" detected by the gamma detector probe is detected, an incision for SLNBx will proceed. A hot spot is defined as an area of increased radioactivity in the axilla with a fall-off in radioactive counts in adjacent tissue. If a hot spot is not detected, transcutaneous probing will continue at 3 minute intervals until this value is reached. In an effort to not prolong the anesthesia time, incision at 30 minutes will be performed even if a hot spot is not identified transcutaneously.

No changes will be made to the method of SLNBx for this study. As axillary lymph node dissection is no longer the standard of care at the time of SLNBx in partial mastectomy, we will continue the practice of sending the SLN for permanent sectioning, however this will be at the surgeon's discretion. If at the time of surgery there are histologically metastatic nodes or if a sentinel node cannot be identified, the surgeon can proceed to axillary lymph node dissection at their discretion, however for the purposes of this study only SLN data will be tracked (please see below for further information on data collection).

Description of method for SLNBx:

After the intradermal injection of tilmanocept or TSC and sub-areolar injection of methylene blue, and the decision to proceed with SLNBx, the standard incision will be made in the axilla overlying the area with the most counts per second per the gamma probe. The subcutaneous tissues are then dissected to the clavipectoral fascia. The fascia is then incised and the axilla is again probed with the gamma probe. Once a blue node or radioactive node(s) is detected they are excised. A radioactive node will be defined as having counts per second that are 10 times higher than surrounding tissue (background count). Once excised, an "ex-vivo" count will be taken of the sentinel node(s) and recorded. If the background radiation of the axilla is less than 10% the counts per second (cps) of the "hottest" harvested sentinel lymph node, the search for radioactive sentinel nodes will be deemed complete. If there is greater than 10% the counts per second remaining in the axilla, then additional nodes will be identified and excised using the same methods until the background radiation is less than 10% the counts per second of the hottest sentinel nodes removed. Additional nodes which are blue but not radioactive will be excised, as will any clinically suspicious nodes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
86

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Georgia
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women above 18 years of age with biopsy proven, clinically stage 1 or 2 breast cancer who will be undergoing partial mastectomy with SLNBx at Memorial Health

Exclusion Criteria:

  • Women under the age of 18,
  • Clinically positive axillary nodes
  • Neoadjuvant therapy for current breast cancer diagnosis
  • Women with previous SLNBx or axillary node dissection
  • Pregnant women
  • Women with previous radiation above the diaphragm, and below the neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Tilmanocept
Tc 99m tilmanocept
Drug: Tc 99m tilmanocept
lymphatic mapping agent
Other Names:
  • LymphoSeek
Active Comparator: Sulfur Colloid
Tc 99m filtered sulfur colloid
Drug: Tc 99m filtered sulfur colloid
lymphatic mapping agent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of harvested lymph nodes
Time Frame: 1 day
Looking for differences between the treatment arms in the number of harvest sentinel lymph nodes
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Health University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: William Burak, MD, Memorial Health University Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 22, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 22, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 22, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 23, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 23, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 27, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016.12.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Tc 99m tilmanocept

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings