Breast CancerNCT06276439
Intraoperative Imaging of Lymph Nodes
An observational study of Breast Cancer, run by University of Illinois at Urbana-Champaign at 1 site in North Macedonia.
Trial summary
One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). 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?
- Surgical removal of breast cancer and lymph nodes
- Type of treatment
- Surgery or procedure
- How many people
- 48 participants
- Where
- 1 siteNorth Macedonia
- Study dates
- 19 Feb 2024to 19 Feb 2026
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: The population we are studying has been diagnosed with early or progressive stage of breast cancer who need to be treated with breast surgery. The participants will undergo breast tumor removal per standard practices.
Who may be able to join
- early or progressive stage of breast cancer who needs to be treated with breast surgery
Who cannot join
- pregnant women
- previous breast cancer surgery
- history of allergic reactions to iodide or seafood allergy.
- man
Trial locations and contacts
1 site in 1 country.
North Macedonia1 site, 1 recruiting
- Recruiting
University Clinic Hospital
Skopje, 1000
Viktor Gruev, PhD, +1.267.847.4020, vgruev@illinois.edu
Goran Kondov, MD, PHD, +389 70 252010, kondov@yahoo.com
About this study
Official title: Intraoperative Imaging of Indocyanine Green for Sentinel Lymph Node Mapping
One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers.
Read the detailed description
The objective of this study is to evaluate the sensitivity of our two new imaging technologies (bioinspired imaging sensor and low noise imaging sensor) to detect positive sentinel lymph nodes in patients with breast cancer. We will achieve this by recording fluorescence emitted by an FDA-approved fluorescent probe known as Indocyanine Green (ICG) in ex vivo resected samples. ICG is routinely used during cancer surgeries around the world because it passively accumulates in sentinel lymph nodes. Due to the bright green coloration of ICG, surgeons can visually identify the location of the sentinel lymph node, resect them and stage the patient's cancer based on pathology results. Since ICG is also fluorescent in the near infrared spectrum, our imaging sensor can locate the sentinel lymph node quicker and more accurately than when using unaided visual inspection. Once the lymph node is located using near-infrared (NIR) imaging with indocyanine green (ICG), the extracted samples will be placed on a separate table. These samples will be subjected to ultraviolet (UV) light to check for any natural autofluorescence. A strong autofluorescence indicates the sample is likely positive or metastatic, suggesting the presence of cancer cells. Subsequent histopathological analysis will further examine these samples. The findings will be used to construct a receiver operating curve, which will help in determining the accuracy of detecting cancer-positive lymph nodes using both exogenous (ICG-induced) and endogenous (natural) fluorescence with the two imaging systems.
- Conditions
- Breast Cancer
- Being tested
- Surgical removal of breast cancer and lymph nodes
- Keywords
- breast cancer, autofluorescence, near infrared fluorescence, Indocyanine Green, ICG
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical removal of breast cancer and lymph nodesProcedure or surgery
The patients will undergo a surgical procedure to remove tumor tissue in the breast and its associated lymph nodes. No clinical decision is based on the imaging device tested.
| Study group | Role | What they receive |
|---|---|---|
| Positive lymph node detection with bioinspired sensor | We will assess the effectiveness of our bioinspired sensor in identifying affected lymph nodes in ex vivo samples. This innovative sensor integrates spectral filters and vertically aligned photodiodes, mirroring the visual capabilities of the mantis shrimp, to simultaneously capture intrinsic UV fluorescence and externally introduced NIR fluorescence from ICG.
To minimize the potential harm from UV radiation, we employ a phased imaging approach. Initially, ICG is injected near the tumor area in the patient, utilizing its NIR fluorescence to accurately locate the lymph node and facilitate the removal of nearby fatty tissue as necessary. Following this, UV light is momentarily used to detect autofluorescence from amino acids frequently found in tumors, providing insights into the lymph node's condition. All resected samples will be analyzed by pathologist and provide ground truth. Receives: Procedure: Surgical removal of breast cancer and lymph nodes | |
| Positive lymph node detection with highly sensitive imaging sensor | We will evaluate the performance of our sensor, characterized by low noise and high quantum efficiency, in detecting compromised lymph nodes in ex vivo samples. This advanced sensor combine spectral filters and low noise photodiodes, enabling the simultaneous detection of natural UV fluorescence and induced NIR fluorescence from ICG.
To minimize the potential harm from UV radiation, we employ a phased imaging approach. Initially, ICG is injected near the tumor area in the patient, utilizing its NIR fluorescence to accurately locate the lymph node and facilitate the removal of nearby fatty tissue as necessary. Following this, UV light is momentarily used to detect autofluorescence from amino acids frequently found in tumors, providing insights into the lymph node's condition. All resected samples will be analyzed by pathologist and provide ground truth. Receives: Procedure: Surgical removal of breast cancer and lymph nodes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive lymph node detection with custom sensors
This study aims to determine the accuracy and reliability of our novel imaging technologies in identifying cancer-affected sentinel lymph nodes in breast cancer patients. Initially, we will utilize the NIR fluorescence from ICG to identify the location of lymph nodes in resected ex vivo samples. Following this, the identified lymph nodes will be exposed to UV light to detect any inherent autofluorescence. Once the imaging study is completed, a pathologist will examine all the surgically removed samples to determine whether there is metastasis in the lymph nodes, thereby establishing the definitive diagnosis.
Measured: The sample removed from the patient will be promptly imaged using our sensor, with the imaging process expected to last between 3 to 5 minutes for each sample.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2024
- Study start19 Feb 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion19 Feb 2026 (estimated)
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 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. National Science Foundation, Ss. Cyril and Methodius University of Skopje
- Responsible party
- Sponsor
- Investigators
- Viktor Gruev, PhD, Principal investigator, University of Illinois Urbana Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06276439
- Sponsor's protocol ID
- IRB23-0314
- Status last verified
- Feb 2024
- First submitted
- 15 Feb 2024
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Blair S, Garcia M, Davis T, Zhu Z, Liang Z, Konopka C, Kauffman K, Colanceski R, Ferati I, Kondov B, Stojanoski S, Todorovska MB, Dimitrovska NT, Jakupi N, Miladinova D, Petrusevska G, Kondov G, Dobrucki WL, Nie S, Gruev V. Hexachromatic bioinspired camera for image-guided cancer surgery. Sci Transl Med. 2021 May 5;13(592):eaaw7067. doi: 10.1126/scitranslmed.aaw7067.
PubMed 33952675Chen C, Wang Z, Wu J, Deng Z, Zhang T, Zhu Z, Jin Y, Lew B, Srivastava I, Liang Z, Nie S, Gruev V. Bioinspired, vertically stacked, and perovskite nanocrystal-enhanced CMOS imaging sensors for resolving UV spectral signatures. Sci Adv. 2023 Nov 3;9(44):eadk3860. doi: 10.1126/sciadv.adk3860. Epub 2023 Nov 3.
PubMed 37922355
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Imaging of Indocyanine Green for Sentinel Lymph Node Mapping
- ClinicalTrials.gov ID
- NCT06276439
- Acronym / sponsor ID
- IRB23-0314
- Conditions
- Breast Cancer
- Keywords
- breast cancer, autofluorescence, near infrared fluorescence, Indocyanine Green, ICG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- U.S. National Science Foundation, Ss. Cyril and Methodius University of Skopje
- Study start
- 19 Feb 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 19 Feb 2026 (estimated)
- First posted
- 26 Feb 2024 (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.
One-third of the global population battles cancer, with surgery being the primary treatment for localized forms. Successful treatment often hinges on the thorough removal of primary tumors and pinpointing cancerous sentinel lymph nodes (SLN). Although modern surgical imaging and fluorescent probes enhance the detection of sentinel lymph nodes using near-infrared (NIR) fluorescence, their inability to precisely determine the nodes' status can result in additional surgeries, lymphedema, and a reduced quality of life for patients. Our research direction aims to harness the potential of bioinspired imaging technologies with the goal of precisely identifying SLN status and ensuring only the cancerous lymph nodes are excised during the initial procedure. To realize this objective, we're drawing inspiration from the mantis shrimp's visual system to create a single-chip multispectral camera that spans the deep ultraviolet to the near-infrared spectrum. Our pioneering sensor seamlessly combines perovskite nanocrystals, optical filters, and vertically-aligned photodetectors on a single chip, enabling concurrent imaging of external NIR fluorophores and internal UV fluorescence from tumor-specific markers.
Detailed description
The objective of this study is to evaluate the sensitivity of our two new imaging technologies (bioinspired imaging sensor and low noise imaging sensor) to detect positive sentinel lymph nodes in patients with breast cancer. We will achieve this by recording fluorescence emitted by an FDA-approved fluorescent probe known as Indocyanine Green (ICG) in ex vivo resected samples. ICG is routinely used during cancer surgeries around the world because it passively accumulates in sentinel lymph nodes. Due to the bright green coloration of ICG, surgeons can visually identify the location of the sentinel lymph node, resect them and stage the patient's cancer based on pathology results. Since ICG is also fluorescent in the near infrared spectrum, our imaging sensor can locate the sentinel lymph node quicker and more accurately than when using unaided visual inspection. Once the lymph node is located using near-infrared (NIR) imaging with indocyanine green (ICG), the extracted samples will be placed on a separate table. These samples will be subjected to ultraviolet (UV) light to check for any natural autofluorescence. A strong autofluorescence indicates the sample is likely positive or metastatic, suggesting the presence of cancer cells. Subsequent histopathological analysis will further examine these samples. The findings will be used to construct a receiver operating curve, which will help in determining the accuracy of detecting cancer-positive lymph nodes using both exogenous (ICG-induced) and endogenous (natural) fluorescence with the two imaging systems.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive lymph node detection with bioinspired sensor | – | Procedure: Surgical removal of breast cancer and lymph nodesWe will assess the effectiveness of our bioinspired sensor in identifying affected lymph nodes in ex vivo samples. This innovative sensor integrates spectral filters and vertically aligned photodiodes, mirroring the visual capabilities of the mantis shrimp, to simultaneously capture intrinsic UV fluorescence and externally introduced NIR fluorescence from ICG. To minimize the potential harm from UV radiation, we employ a phased imaging approach. Initially, ICG is injected near the tumor area in the patient, utilizing its NIR fluorescence to accurately locate the lymph node and facilitate the removal of nearby fatty tissue as necessary. Following this, UV light is momentarily used to detect autofluorescence from amino acids frequently found in tumors, providing insights into the lymph node's condition. All resected samples will be analyzed by pathologist and provide ground truth. |
| Positive lymph node detection with highly sensitive imaging sensor | – | Procedure: Surgical removal of breast cancer and lymph nodesWe will evaluate the performance of our sensor, characterized by low noise and high quantum efficiency, in detecting compromised lymph nodes in ex vivo samples. This advanced sensor combine spectral filters and low noise photodiodes, enabling the simultaneous detection of natural UV fluorescence and induced NIR fluorescence from ICG. To minimize the potential harm from UV radiation, we employ a phased imaging approach. Initially, ICG is injected near the tumor area in the patient, utilizing its NIR fluorescence to accurately locate the lymph node and facilitate the removal of nearby fatty tissue as necessary. Following this, UV light is momentarily used to detect autofluorescence from amino acids frequently found in tumors, providing insights into the lymph node's condition. All resected samples will be analyzed by pathologist and provide ground truth. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population we are studying has been diagnosed with early or progressive stage of breast cancer who need to be treated with breast surgery. The participants will undergo breast tumor removal per standard practices.
Key inclusion criteria (1 listed)
- early or progressive stage of breast cancer who needs to be treated with breast surgery
Key exclusion criteria (4 listed)
- pregnant women
- previous breast cancer surgery
- history of allergic reactions to iodide or seafood allergy.
- man
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 |
|---|---|---|
| Surgical removal of breast cancer and lymph nodesThe patients will undergo a surgical procedure to remove tumor tissue in the breast and its associated lymph nodes. No clinical decision is based on the imaging device tested. | Procedure or surgery | Positive lymph node detection with bioinspired sensor, Positive lymph node detection with highly sensitive imaging sensor |
Primary outcome
Positive lymph node detection with custom sensors
Time frame: The sample removed from the patient will be promptly imaged using our sensor, with the imaging process expected to last between 3 to 5 minutes for each sample.
This study aims to determine the accuracy and reliability of our novel imaging technologies in identifying cancer-affected sentinel lymph nodes in breast cancer patients. Initially, we will utilize the NIR fluorescence from ICG to identify the location of lymph nodes in resected ex vivo samples. Following this, the identified lymph nodes will be exposed to UV light to detect any inherent autofluorescence. Once the imaging study is completed, a pathologist will examine all the surgically removed samples to determine whether there is metastasis in the lymph nodes, thereby establishing the definitive diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 33952675Blair S, Garcia M, Davis T, Zhu Z, Liang Z, Konopka C, Kauffman K, Colanceski R, Ferati I, Kondov B, Stojanoski S, Todorovska MB, Dimitrovska NT, Jakupi N, Miladinova D, Petrusevska G, Kondov G, Dobrucki WL, Nie S, Gruev V. Hexachromatic bioinspired camera for image-guided cancer surgery. Sci Transl Med. 2021 May 5;13(592):eaaw7067. doi: 10.1126/scitranslmed.aaw7067.
- Background: PubMed 37922355Chen C, Wang Z, Wu J, Deng Z, Zhang T, Zhu Z, Jin Y, Lew B, Srivastava I, Liang Z, Nie S, Gruev V. Bioinspired, vertically stacked, and perovskite nanocrystal-enhanced CMOS imaging sensors for resolving UV spectral signatures. Sci Adv. 2023 Nov 3;9(44):eadk3860. doi: 10.1126/sciadv.adk3860. Epub 2023 Nov 3.
- 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
University of Illinois Urbana Champaign
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 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 1 inclusion and 4 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 26 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Viktor Gruev, PhD (+1.267.847.4020, vgruev@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive lymph node detection with custom sensors (time frame: The sample removed from the patient will be promptly imaged using our sensor, with the imaging process expected to last between 3 to 5 minutes for each sample.). 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 NCT06276439, 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 26 Feb 2024.