Breast CancerNCT05236387
Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
An observational study of Breast Cancer, run by Johns Hopkins University at 1 site in United States.
Trial summary
The purpose of the present study is to evaluate the ability of 99mTc-TM to identify the clipped node after neoadjuvant chemotherapy (NAC) and to compare this percentage with historical national data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 99m Tc-TM
- Type of treatment
- Injection or infusion
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2022to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intent-to-treat population All patients meeting entrance criteria, injected with 99mTc-TM, and having one or more lymph nodes removed for which the pathologist confirms the type (lymph node versus non-lymph node) and contents (e.g., tumor cells) of the excised tissues will comprise the intent-to-treat population (ITT). This definition also carries over to the lymph nodes; i.e., nodes used for the ITT analysis must come from patients included in the ITT population. The ITT population will serve as the analysis population for all efficacy endpoints, unless indicated otherwise in the description of analyses.
Who may be able to join
- The patient has provided written informed consent with HIPAA authorization.
- The patient is female or male and ≥18 years of age at the time of consent.
- The patient has been diagnosed with invasive Stage 2-3 breast cancer (T1-3; N1-2).
- The patient has no history of inflammatory breast cancer.
- The patient has no matted node on examination (N3).
- The patient is eligible for neoadjuvant chemotherapy (NAC).
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- The patient is a candidate for surgical intervention, with sentinel lymph node assessment being a part of the surgical plan.
- If of childbearing potential, the patient has a negative pregnancy test within 48 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year.
- The patient has no known allergies or hypersensitivity to 99mTc-TM, BD, or India ink.
Who cannot join
- The patient is pregnant or lactating.
- The patient has clinical and/or radiological evidence of metastatic or systemic disease. Oligo metastatic disease is acceptable (one organ and controlled).
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bayview Hospital
Baltimore, Maryland, 21224
About this study
Official title: A Single-Center, Open-Label Study Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
The purpose of the present study is to evaluate the ability of 99mTc-TM to identify the clipped node after neoadjuvant chemotherapy (NAC) and to compare this percentage with historical national data. This study will also evaluate pain and discomfort after injection and pathological features of clipped nodes and any additional nodes removed.
Read the detailed description
This is a phase 4 single-center, open-label, single-arm study evaluating the ability of 99mTc-TM to identify clipped nodes in primary breast cancer patients receiving NAC and subsequent Sentinel Lymph Node Biopsy (SLNB) as practice compared to published historical data . Sixty-four (64) patients (≥18 years) diagnosed with breast cancer and who are evaluated as having a favorable response (i.e., at least partial clinical response in the breast) to chemotherapy during the mid-treatment evaluation will be evaluated in this study. Patients will have suspicious lymph nodes assessed and one biopsied for pathological evaluation and clipped during the course of the patients' medical work-up. Patients will undergo NAC treatment and have a mid-treatment evaluation to assess response to the chemotherapy. Patients with a favorable response will complete NAC followed by identification of the clipped node and sentinel lymph nodes and standard lymph node assessment. Patients with an unfavorable response (i.e., no response to the NAC) will continue NAC but will not continue to participate in the study. All study patients undergoing SLNB will receive a single injection (0.1 ml) of 99mTc-TM (50 mcg) preoperatively. If no signal is detected within 30-60 minutes, patients may also be injected with BD (up to 10 cc), intraoperatively. Pain at injection site will be assessed pre-injection and at 1 minute after the 99mTc-TM injection.
It is anticipated that the majority of patients enrolled will receive NAC treatment. Although chemotherapy will be the primary neoadjuvant treatment used in this study, if the investigator feels the patient will benefit more from hormonal therapy, a hormonal treatment will be administered.
- Conditions
- Breast Cancer
- Being tested
- 99m Tc-TM
- Keywords
- Lymphoseek, Sentinel Lymph Nodes, Neo Adjuvant Chemotherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
99m Tc-TMDrug
Also called Lymphoseek
Each patient will receive a single injection (0.1 ml) of 99mTc-TM (50 mcg) at the upper outer skin of the breast using an intradermal technique confirmed by the presence of a skin wheal.
| Study group | Role | What they receive |
|---|---|---|
| Intent to Treat group | All patients meeting entrance criteria, injected with 99m Tc-TM, and having one or more lymph nodes removed for which the pathologist confirms the type (lymph node versus non-lymph node) and contents (e.g., tumor cells) of the excised tissues will comprise the intent-to-treat population (ITT). This definition also carries over to the lymph nodes; i.e., nodes used for the ITT analysis must come from patients included in the ITT population. The ITT population will serve as the analysis population for all efficacy endpoints, unless indicated otherwise in the description of analyses. Receives: Drug: 99m Tc-TM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of clipped nodes detected with 99m Tc-Tm intraoperatively as determined with a hand held gamma detection device
The percentage of clipped nodes identified using 99mTc-TM will be calculated, along with an exact binomial 95% confidence interval.
Measured: 1 month after the surgery
Secondary outcomes (3)
Change in Pain at injection site as assessed by a visual analog scale
Pain Assessment will be performed before injecting 99m Tc-TM and approximately 1 minute after the injection. Injection site pain will be assessed using a standardized visual analog scale (VAS). The VAS is a horizontal line measuring 0-100 mm in length, anchored by word descriptors at each end. The left end (0 mm) is labeled "no pain" and the right end (100 mm) is labeled "worst pain imaginable". The patient will be instructed to make a vertical mark on the horizontal line that they feel represents their pain intensity. The VAS is scored manually by measurement in millimeters from the left side of the line (0 mm) to the point where the patient marks on the horizontal line.
Measured: Immediately before injection and at 1 minute after injection
Number of clipped nodes that were SLNs
Number of clipped nodes that were Sentinel Lymph Nodes (SLNs).
Measured: 1 month after the surgery
Concordance of blue/hot nodes for clipped and SLNs as assessed by Lymphoseek with the highest counts on the Gamma counter
To study the pathological features of the clipped node and any additional nodes (attempt for 2-3 total sentinel lymph node assessment, as standard practice) identified by Lymphoseek with the highest counts on the Gamma counter (10% rule).
Measured: 1 month after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Mar 2022
- Primary completion23 May 2023
- Study completion30 Jun 2023
Why it stopped: PI left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardinal Health
- Responsible party
- Sponsor
- Investigators
- Mehran Habibi, MD, Principal investigator, Johns Hopkins Bayview
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05236387
- Sponsor's protocol ID
- IRB00154162
- Status last verified
- Feb 2024
- First submitted
- 18 Jan 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center, Open-Label Study Evaluating the Ability of 99mTc-Tilmanocept to Identify Clipped Nodes in Breast Cancer Patients Undergoing Neoadjuvant Chemotherapy and Sentinel Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT05236387
- Acronym / sponsor ID
- IRB00154162
- Conditions
- Breast Cancer
- Keywords
- Lymphoseek, Sentinel Lymph Nodes, Neo Adjuvant Chemotherapy
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: PI left institution
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Cardinal Health
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 23 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 11 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the present study is to evaluate the ability of 99mTc-TM to identify the clipped node after neoadjuvant chemotherapy (NAC) and to compare this percentage with historical national data. This study will also evaluate pain and discomfort after injection and pathological features of clipped nodes and any additional nodes removed.
Detailed description
This is a phase 4 single-center, open-label, single-arm study evaluating the ability of 99mTc-TM to identify clipped nodes in primary breast cancer patients receiving NAC and subsequent Sentinel Lymph Node Biopsy (SLNB) as practice compared to published historical data . Sixty-four (64) patients (≥18 years) diagnosed with breast cancer and who are evaluated as having a favorable response (i.e., at least partial clinical response in the breast) to chemotherapy during the mid-treatment evaluation will be evaluated in this study. Patients will have suspicious lymph nodes assessed and one biopsied for pathological evaluation and clipped during the course of the patients' medical work-up. Patients will undergo NAC treatment and have a mid-treatment evaluation to assess response to the chemotherapy. Patients with a favorable response will complete NAC followed by identification of the clipped node and sentinel lymph nodes and standard lymph node assessment. Patients with an unfavorable response (i.e., no response to the NAC) will continue NAC but will not continue to participate in the study. All study patients undergoing SLNB will receive a single injection (0.1 ml) of 99mTc-TM (50 mcg) preoperatively. If no signal is detected within 30-60 minutes, patients may also be injected with BD (up to 10 cc), intraoperatively. Pain at injection site will be assessed pre-injection and at 1 minute after the 99mTc-TM injection.
It is anticipated that the majority of patients enrolled will receive NAC treatment. Although chemotherapy will be the primary neoadjuvant treatment used in this study, if the investigator feels the patient will benefit more from hormonal therapy, a hormonal treatment will be administered.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intent to Treat group | – | Drug: 99m Tc-TMAll patients meeting entrance criteria, injected with 99m Tc-TM, and having one or more lymph nodes removed for which the pathologist confirms the type (lymph node versus non-lymph node) and contents (e.g., tumor cells) of the excised tissues will comprise the intent-to-treat population (ITT). This definition also carries over to the lymph nodes; i.e., nodes used for the ITT analysis must come from patients included in the ITT population. The ITT population will serve as the analysis population for all efficacy endpoints, unless indicated otherwise in the description of analyses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intent-to-treat population All patients meeting entrance criteria, injected with 99mTc-TM, and having one or more lymph nodes removed for which the pathologist confirms the type (lymph node versus non-lymph node) and contents (e.g., tumor cells) of the excised tissues will comprise the intent-to-treat population (ITT). This definition also carries over to the lymph nodes; i.e., nodes used for the ITT analysis must come from patients included in the ITT population. The ITT population will serve as the analysis population for all efficacy endpoints, unless indicated otherwise in the description of analyses.
Key inclusion criteria (9 listed)
- The patient has provided written informed consent with HIPAA authorization.
- The patient is female or male and ≥18 years of age at the time of consent.
- The patient has been diagnosed with invasive Stage 2-3 breast cancer (T1-3; N1-2).
- The patient has no history of inflammatory breast cancer.
- The patient has no matted node on examination (N3).
Key exclusion criteria (2 listed)
- The patient is pregnant or lactating.
- The patient has clinical and/or radiological evidence of metastatic or systemic disease. Oligo metastatic disease is acceptable (one organ and controlled).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 99m Tc-TMAlso: LymphoseekEach patient will receive a single injection (0.1 ml) of 99mTc-TM (50 mcg) at the upper outer skin of the breast using an intradermal technique confirmed by the presence of a skin wheal. | Drug | Intent to Treat group |
Primary outcome
Percentage of clipped nodes detected with 99m Tc-Tm intraoperatively as determined with a hand held gamma detection device
Time frame: 1 month after the surgery
The percentage of clipped nodes identified using 99mTc-TM will be calculated, along with an exact binomial 95% confidence interval.
3 secondary outcomes
Change in Pain at injection site as assessed by a visual analog scale
Time frame: Immediately before injection and at 1 minute after injection
Number of clipped nodes that were SLNs
Time frame: 1 month after the surgery
Concordance of blue/hot nodes for clipped and SLNs as assessed by Lymphoseek with the highest counts on the Gamma counter
Time frame: 1 month after the surgery
Results and safety
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehran Habibi, MD principal investigator
Johns Hopkins Bayview
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of clipped nodes detected with 99m Tc-Tm intraoperatively as determined with a hand held gamma detection device (time frame: 1 month after the surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.