Breast CancerNCT03619967
Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
A study testing Multispectral imager in people with Breast Cancer, run by University of Illinois at Urbana-Champaign at 1 site in North Macedonia.
Trial summary
Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Read more about this study
- Who is it for?
- Ages 17 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Multispectral imager
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 20 Jul 2018to 25 May 2022
- 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 17 to 80 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- early or progressive stage of breast cancer
- able to understand and willing to sign a written informed consent document
Who cannot join
- inflammatory cancerous tissue
- pregnant women
- history of allergic reactions to iodide or seafood allergy
- sentinel lymph nodes were not detected with radiocolloid and static gamma camera
- patients have previous breast surgery
- patients who were unwilling to enter the study
Trial locations and contacts
1 site in 1 country.
About this study
Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. The clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images.
To address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. The objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.
Read the detailed description
Per current standard of care for patients with breast cancer, three different tracers will be injected in the participants: technetium radiocolloid, indocyanine green and methylene blue. Initially, the surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. While the surgeon is locating the sentinel lymph nodes in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the bio-inspired multispectral camera.
All resected tissue from the patient will be imaged with the multispectral camera before sending samples for pathology analysis. Results obtained from the multispectral cameras will not be presented to the surgeon during the surgery in order not to influence their surgical decision.
- Conditions
- Breast Cancer
- Being tested
- Multispectral imager
- Keywords
- breast cancer, sentynel lymph node, fluorescence imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multispectral imagerDevice
Device: Bio-inspired multispectral imager
-Manufactured at University of Illinois at Urbana Champaign
| Study group | Role | What they receive |
|---|---|---|
| Multispectral imaging device | Experimental | Bio-inspired multispectral imaging device will be used to record fluorescence signals emited by dyes (Indocyanine green and methylene blue) routinely used for visual identification of sentinel lymph nodes per current standard of care worldwide. Receives: Device: Multispectral imager |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.
The patient will be admitted to the hospital one day before the surgery and will be treated without deviating from normal operating procedures for this surgical procedure. The patient will be first administered radiocolloid tracer per current standard of care and scanned with a double-headed SPECT gamma camera to locate sentinel lymph nodes (SLN).
The patient is moved to the operating room next. After the patient undergoes anesthesia, methylene blue and indocyanine green will be administered. The surgeon will look to locate radioactive activity and coloration from methylene blue and indocyanine green.
While the surgeon is locating the SLN in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the multispectral camera. After the location of the sentinel lymph node, the surgeon will resect this tissue and with a handheld gamma probe will test for accumulation of the radio tracer.
Measured: Up to 1 week after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start20 Jul 2018
- Primary completion25 May 2022
- Study completion25 May 2022
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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Experimental: Arm 1: Multispectral Imaging Per current standard of care for patients with breast cancer, three different tracers will be injected in the patient: technetium radiocolloid, indocyanine green and methylene blue. The surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. During this same time period, fluorescent signals from the underarm surgical wound site will be recorded with the bio-inspired multispectral camera.
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Ss. Cyril and Methodius University of Skopje
- Responsible party
- Principal investigator, Viktor Gruev, PhD, University of Illinois at Urbana-Champaign
- Investigators
- Viktor Gruev, PhD, Principal investigator, UIUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03619967
- Sponsor's protocol ID
- 18947
- Status last verified
- May 2022
- First submitted
- 17 Jul 2018
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sentinel Lymph Node Mapping With Near Infrared Fluorescent Markers
- ClinicalTrials.gov ID
- NCT03619967
- Acronym / sponsor ID
- 18947
- Conditions
- Breast Cancer
- Keywords
- breast cancer, sentynel lymph node, fluorescence imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Ss. Cyril and Methodius University of Skopje
- Study start
- 20 Jul 2018 (actual)
- Primary completion
- 25 May 2022 (actual)
- Study completion
- 25 May 2022 (actual)
- First posted
- 8 Aug 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.
Surgery is the primary curative option for patients with cancer, with the overall objective of complete resection of all cancerous tissue while avoiding damage to healthy tissue. In addition, sentinel lymph node (SLN) mapping and resection is an essential step in staging and managing the disease. Even with the latest advancements in imaging technology, incomplete tumor resection in patients with breast cancer is at an alarming rate of 20-25%, with recurrence rates of up to 27%. The clinical need for imaging instruments that provide real-time feedback in the operating room is unmet, largely due to the use of imaging systems based on contemporary technological advances in the semiconductor and optical fields, which have bulky and costly designs with suboptimal sensitivity and co-registration accuracy between multimodal images.
To address these challenges, the investigators have introduced an innovative design comprising a bio-inspired multispectral sensor which can significantly improve image-guided surgery. The objective of this clinical study is to determine the feasibility of using a bio-inspired multispectral imaging system to detect sentinel lymph nodes and cancerous tissue during intraoperative procedures in patients with breast cancer.
Detailed description
Per current standard of care for patients with breast cancer, three different tracers will be injected in the participants: technetium radiocolloid, indocyanine green and methylene blue. Initially, the surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. While the surgeon is locating the sentinel lymph nodes in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the bio-inspired multispectral camera.
All resected tissue from the patient will be imaged with the multispectral camera before sending samples for pathology analysis. Results obtained from the multispectral cameras will not be presented to the surgeon during the surgery in order not to influence their surgical decision.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Experimental: Arm 1: Multispectral Imaging Per current standard of care for patients with breast cancer, three different tracers will be injected in the patient: technetium radiocolloid, indocyanine green and methylene blue. The surgeon will identify the location of the sentinel lymph node per standard of care by using a handheld gamma-probe and by visual inspection of the wound site. During this same time period, fluorescent signals from the underarm surgical wound site will be recorded with the bio-inspired multispectral camera.
| Arm | Type | Receives |
|---|---|---|
| Multispectral imaging device | Experimental | Device: Multispectral imagerBio-inspired multispectral imaging device will be used to record fluorescence signals emited by dyes (Indocyanine green and methylene blue) routinely used for visual identification of sentinel lymph nodes per current standard of care worldwide. |
Who may qualify
- Ages
- 17 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- early or progressive stage of breast cancer
- able to understand and willing to sign a written informed consent document
Key exclusion criteria (6 listed)
- inflammatory cancerous tissue
- pregnant women
- history of allergic reactions to iodide or seafood allergy
- sentinel lymph nodes were not detected with radiocolloid and static gamma camera
- patients have previous breast surgery
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 |
|---|---|---|
| Multispectral imagerDevice: Bio-inspired multispectral imager -Manufactured at University of Illinois at Urbana Champaign | Device | Multispectral imaging device |
Primary outcome
Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue.
Time frame: Up to 1 week after surgery
The patient will be admitted to the hospital one day before the surgery and will be treated without deviating from normal operating procedures for this surgical procedure. The patient will be first administered radiocolloid tracer per current standard of care and scanned with a double-headed SPECT gamma camera to locate sentinel lymph nodes (SLN). The patient is moved to the operating room next. After the patient undergoes anesthesia, methylene blue and indocyanine green will be administered. The surgeon will look to locate radioactive activity and coloration from methylene blue and indocyanine green. While the surgeon is locating the SLN in the underarm surgical wound site, the investigators will be recording the fluorescent signals from the same site with the multispectral camera. After the location of the sentinel lymph node, the surgeon will resect this tissue and with a handheld gamma probe will test for accumulation of the radio tracer.
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 25 May 2022.
- 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.
Viktor Gruev, PhD principal investigator
UIUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multispectral imager in people with Breast Cancer, run by University of Illinois at Urbana-Champaign at 1 site in North Macedonia.
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 2 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: finished, as of the sponsor's last update on 25 May 2022. 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 North Macedonia. 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?
Fluorescence imaging of sentinel lymph nodes with indocyanine green and methylene blue. (time frame: Up to 1 week after 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 25 May 2022.