Sentinel Lymph NodeNCT03579979
Sentinel Lymph Node Biopsy in Breast Cancer Surgery Using ICG
A study testing Methylene Blue and Indocyanine Green in people with Sentinel Lymph Node and Breast Cancer, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Sentinel Lymph Node, Breast Cancer
- What is being tested?
- Methylene Blue and Indocyanine Green
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 24 Aug 2017to 19 Aug 2020
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the age of 18-75 years, female patients;
- the diagnosis of breast cancer by biopsy;
- participants voluntarily participated in the clinical trial and signed informed consent.
Who cannot join
- had received SLNB or axillary surgery;
- breast area radiotherapy or neoadjuvant chemotherapy has been accepted.
- clinical hints of axillary lymph node metastasis;
- discovery of distant metastasis;
- inflammatory breast cancer;
- women in pregnancy;
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- people with iodine allergy;
- the serum creatinine was > 1.5 times as high as the upper limit of the normal value.
- to participate in clinical trials of other devices or drugs within one month;
- the researchers consider it inappropriate to participate in this clinical trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Key Laboratory of Molecular Imaging, Chinese Academy of Sciences
Beijing, Beijing Municipality, 100190
About this study
Official title: To Evaluate the Safety and Efficacy of Near-infarred Fluorescence Molecular Imaging in the Prospective, Multi-center and Self-controlled Clinical Trial of Sentinel Lymph Node Biopsy in Breast Cancer Surgery
This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine green (ICG) on imaging detection and the control group, routine medical using methylene blue test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared.
Read the detailed description
This trial was a prospective, multicenter, and self controlled clinical trial. The subjects who were in line with this scheme were detected by fluorimetry and staining, and the primary effectiveness evaluation index, secondary effectiveness evaluation index and safety evaluation index were established during the operation. Record evaluation. At present, in the clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue staining method. A large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7. Therefore, choosing a self controlled clinical trial can increase the number of sentinel lymph node detection.
- Conditions
- Sentinel Lymph Node, Breast Cancer
- Being tested
- Methylene Blue, Indocyanine Green
- Keywords
- Near-infrared fluorescence, Image guided surgery, Sentinel lymph node biopsy, Indocyanine green, Methylene blue
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylene BlueDrug
Also called MB
Subcutaneous injection of injection point at the periphery of the areola or tumor, injecting 1% methylene blue 0.5ml at each point, a total of 2-3 points.
Indocyanine GreenDrug
Also called ICG
Within 5 minutes after MB injection, 2.5mg/ml ICG 0.5ml was injected at each point, a total of 2-3 points. Methylene blue and ICG injection points do not coincide
| Study group | Role | What they receive |
|---|---|---|
| Self control | Experimental | During the operation, with the fluorescent molecular imaging instrument, the imaging agent (indocyanine green) is illuminated by the probe distance to the tissue surface 10-30cm, and is excited to produce the near infrared fluorescence of the specific wavelength (the human eye is not visible). The system uses a photoelectric coupler to collect the light of the specific spectrum, and the image is collected by the method of correction. The operation was performed to achieve real-time display of lesions.
The injection points were selected subcutaneously around the areola or the periphery of the tumor. 1% methylene blue 0.5ml was injected at each point, with a total of 2-3 points. Within 5 minutes, 2.5mg/ml ICG 0.5ml was injected at each point, with a total of 2-3 points. Receives: Drug: Methylene Blue; Drug: Indocyanine Green |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sentinel lymph node detection number
Participants will be followed for the duration of hospital stay, an expected average of 1 year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2018
- Study start24 Aug 2017
- Primary completion30 Aug 2019
- Study completion19 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sentinel Lymph NodeStudies 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
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Collaborators
- Beijing Digital Precesion Medicine Company, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital, Tangshan People's Hospital, The Second Hospital of Hebei Medical University
- Responsible party
- Principal investigator, Chongwei Chi, Ph.D, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03579979
- Sponsor's protocol ID
- CIP-DPM-02
- Status last verified
- Aug 2021
- First submitted
- 8 Jun 2018
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
He K, Chi C, Kou D, Huang W, Wu J, Wang Y, He L, Ye J, Mao Y, Zhang GJ, Wang J, Tian J. Comparison between the indocyanine green fluorescence and blue dye methods for sentinel lymph node biopsy using novel fluorescence image-guided resection equipment in different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18.
PubMed 27497181Chi C, Ye J, Ding H, He D, Huang W, Zhang GJ, Tian J. Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation. PLoS One. 2013 Dec 16;8(12):e83927. doi: 10.1371/journal.pone.0083927. eCollection 2013.
PubMed 24358319
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Safety and Efficacy of Near-infarred Fluorescence Molecular Imaging in the Prospective, Multi-center and Self-controlled Clinical Trial of Sentinel Lymph Node Biopsy in Breast Cancer Surgery
- ClinicalTrials.gov ID
- NCT03579979
- Acronym / sponsor ID
- CIP-DPM-02
- Conditions
- Sentinel Lymph Node, Breast Cancer
- Keywords
- Near-infrared fluorescence, Image guided surgery, Sentinel lymph node biopsy, Indocyanine green, Methylene blue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- Beijing Digital Precesion Medicine Company, Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital, Tangshan People's Hospital, The Second Hospital of Hebei Medical University
- Study start
- 24 Aug 2017 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 9 Jul 2018 (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.
This clinical trial is a prospective, multicenter, self-controlled clinical study. In order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by Beijing digital precision medical technology co., LTD. The fluorescence molecular imaging of indocyanine green (ICG) on imaging detection and the control group, routine medical using methylene blue test .The safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared.
Detailed description
This trial was a prospective, multicenter, and self controlled clinical trial. The subjects who were in line with this scheme were detected by fluorimetry and staining, and the primary effectiveness evaluation index, secondary effectiveness evaluation index and safety evaluation index were established during the operation. Record evaluation. At present, in the clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue staining method. A large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7. Therefore, choosing a self controlled clinical trial can increase the number of sentinel lymph node detection.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self control | Experimental | Drug: Methylene Blue, Drug: Indocyanine GreenDuring the operation, with the fluorescent molecular imaging instrument, the imaging agent (indocyanine green) is illuminated by the probe distance to the tissue surface 10-30cm, and is excited to produce the near infrared fluorescence of the specific wavelength (the human eye is not visible). The system uses a photoelectric coupler to collect the light of the specific spectrum, and the image is collected by the method of correction. The operation was performed to achieve real-time display of lesions. The injection points were selected subcutaneously around the areola or the periphery of the tumor. 1% methylene blue 0.5ml was injected at each point, with a total of 2-3 points. Within 5 minutes, 2.5mg/ml ICG 0.5ml was injected at each point, with a total of 2-3 points. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- the age of 18-75 years, female patients;
- the diagnosis of breast cancer by biopsy;
- participants voluntarily participated in the clinical trial and signed informed consent.
Key exclusion criteria (10 listed)
- had received SLNB or axillary surgery;
- breast area radiotherapy or neoadjuvant chemotherapy has been accepted.
- clinical hints of axillary lymph node metastasis;
- discovery of distant metastasis;
- inflammatory breast cancer;
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 |
|---|---|---|
| Methylene BlueAlso: MBSubcutaneous injection of injection point at the periphery of the areola or tumor, injecting 1% methylene blue 0.5ml at each point, a total of 2-3 points. | Drug | Self control |
| Indocyanine GreenAlso: ICGWithin 5 minutes after MB injection, 2.5mg/ml ICG 0.5ml was injected at each point, a total of 2-3 points. Methylene blue and ICG injection points do not coincide | Drug | Self control |
Primary outcome
Sentinel lymph node detection number
Time frame: 1 year
Participants will be followed for the duration of hospital stay, an expected average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Results publication: PubMed 27497181He K, Chi C, Kou D, Huang W, Wu J, Wang Y, He L, Ye J, Mao Y, Zhang GJ, Wang J, Tian J. Comparison between the indocyanine green fluorescence and blue dye methods for sentinel lymph node biopsy using novel fluorescence image-guided resection equipment in different types of hospitals. Transl Res. 2016 Dec;178:74-80. doi: 10.1016/j.trsl.2016.07.010. Epub 2016 Jul 18.
- Results publication: PubMed 24358319Chi C, Ye J, Ding H, He D, Huang W, Zhang GJ, Tian J. Use of indocyanine green for detecting the sentinel lymph node in breast cancer patients: from preclinical evaluation to clinical validation. PLoS One. 2013 Dec 16;8(12):e83927. doi: 10.1371/journal.pone.0083927. eCollection 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methylene Blue and Indocyanine Green in people with Sentinel Lymph Node and Breast Cancer, run by Chinese Academy of Sciences 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 3 inclusion and 10 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: finished, as of the sponsor's last update on 4 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sentinel lymph node detection number (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03579979, which also lists 2 linked publications.
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 4 Aug 2021.