Breast CancerLI-CTDNCT04438577
Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery
A study testing Lidocaine mucilage-ICG in people with Breast Cancer, run by Shantou Central Hospital at 1 site in China.
Trial summary
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Lidocaine mucilage-ICG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to Jan 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female at least 18 years old
- Histologically or cytologically confirmed breast carcinoma
- Patients planned to receive a breast-conserving surgery
- Patients received a preoperative breast magnetic resonance imaging
- Informed consent form understood and signed
- Patient agrees to all follow-up visits
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery
Who cannot join
- Psychiatric or other condition that may interfere with the study
- Known allergy or contraindication to any study drug
- Patients received neoadjuvant therapies
- Patients received an excision biopsy of the tumor
- Breast feeding period
- Pregnant (female of childbearing potential only)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shantou Central Hospital
Shantou, Guangdong, 515300
Si-Qi Qiu, Dr., 008613790868950, s_patrick@163.com
About this study
Official title: Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.
- Conditions
- Breast Cancer
- Being tested
- Lidocaine mucilage-ICG
- Keywords
- Breast conserving surgery; fluorescence-guided surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine mucilage-ICGDrug
Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation
| Study group | Role | What they receive |
|---|---|---|
| Efficacy of Lidocaine mucilage-ICG | Experimental | Efficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation Receives: Drug: Lidocaine mucilage-ICG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Margin width
The distance between tumor and margin on the gross specimen
Measured: 7 days
Positive margin rate
The percentage of patients with a positive margin out of the participants
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start20 Aug 2020
- Primary completionJul 2021 (estimated)
- Study completionJan 2024 (estimated)
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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantou Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Qi Qiu, Shantou Central Hospital
- Investigators
- Si-Qi Qiu, Dr., Principal investigator, Shantou Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04438577
- Sponsor's protocol ID
- ShantouCH
- Acronym
- LI-CTD
- Status last verified
- Oct 2020
- First submitted
- 17 Jun 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Feasibility and Efficacy of Lidocaine Mucilage-ICG as an Optical Agent to Detect Cancer Tissue Delineation During Breast-conserving Surgery
- ClinicalTrials.gov ID
- NCT04438577
- Acronym / sponsor ID
- LI-CTD / ShantouCH
- Conditions
- Breast Cancer
- Keywords
- Breast conserving surgery; fluorescence-guided surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shantou Central HospitalUniversity, hospital or other
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- Jul 2021 (estimated)
- Study completion
- Jan 2024 (estimated)
- First posted
- 19 Jun 2020 (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.
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopathology. Currently available modalities used for intraoperative surgical margin assessment all have specific limitations. In order to improve intraoperative tumor localization and surgical margin assessment in BCS, we developed a fluorescent tracer, the Lidocaine mucilage-ICG tracer, which could be locally injected and detected by fluorescent camera systems during operation. In this study, we aim to evaluate the efficacy of Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Efficacy of Lidocaine mucilage-ICG | Experimental | Drug: Lidocaine mucilage-ICGEfficacy of Lidocaine mucilage-ICG for intraoperative tumor delineation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Female at least 18 years old
- Histologically or cytologically confirmed breast carcinoma
- Patients planned to receive a breast-conserving surgery
- Patients received a preoperative breast magnetic resonance imaging
- Informed consent form understood and signed
Key exclusion criteria (6 listed)
- Psychiatric or other condition that may interfere with the study
- Known allergy or contraindication to any study drug
- Patients received neoadjuvant therapies
- Patients received an excision biopsy of the tumor
- Breast feeding period
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 |
|---|---|---|
| Lidocaine mucilage-ICGLidocaine mucilage-ICG as an agent for intraoperative tumor delineation | Drug | Efficacy of Lidocaine mucilage-ICG |
Primary outcome
Margin width
Time frame: 7 days
The distance between tumor and margin on the gross specimen
Positive margin rate
Time frame: 7 days
The percentage of patients with a positive margin out of the participants
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
Si-Qi Qiu, Dr. principal investigator
Shantou Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine mucilage-ICG in people with Breast Cancer, run by Shantou Central Hospital at 1 site in China.
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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 22 Oct 2020. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mian-Han Zhuang (008613750445342, jgbst@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Margin width (time frame: 7 days). The study lists 2 primary outcomes in all. 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 22 Oct 2020.