Breast CancerPhase 1/2NCT05130801
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
A Phase 1/2 study testing pHLIP® ICG NIRF imaging in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
The purpose of this study is to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging… 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?
- pHLIP® ICG NIRF imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 19 Nov 2021to Nov 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- Age 18 years or greater
- Biopsy proven primary breast malignancy (BI-RADS 6)
- Tumor stage Tis, T1 and T2, lesion size > 1 cm
- Primary surgical treatment with breast conservation
- No previous treatment
- ECOG performance of 0-2
Who cannot join
- Life expectancy < 3 months
- Pregnancy or lactation
- Known metastatic liver disease, hepatic neoplasms (benign and malignant), biliary atresia, chronic liver disease (CLD) and cirrhosis.
- Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I)
- Known hypersensitivity to indocyanine green.
- Individuals with impaired-decision making capacity
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Monica Morrow, MD contact
United States2 sites, 2 recruiting
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Giacomo Montagna, MD, 646-888-6891
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Giacomo Montagna, MD, 646-888-6891
About this study
Official title: Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
The purpose of this study is to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to see the tumor and nearby tissues that contain cancer cells more clearly and remove them completely.
During the Phase IIa part of this study, the safe dose of pHLIP ICG will be used that makes it easy for the surgeon to see the tumor and the nearby tissues and structures that may contain cancer cells. This study is the first to test pHLIP ICG in people, and the first to test the use of pHLIP ICG with mpMRI and NIRF imaging in surgery for breast cancer.
Read the detailed description
his protocol involves performing first-in-human imaging with pHLIP® ICG in consecutive patients with newly diagnosed primary BC (tumor stage T1-T2 with or without lymph node metastases) undergoing breast conserving treatment at MSK. All imaging will be obtained either at MRI staging before surgery and during definite surgical treatment; no additional invasive procedures will be necessary.
The information collected in the phase I part of this study will not be used for diagnostic purposes, and neither will the information be used to assess the patients' response to therapy nor adjust the clinical management of the patient.
During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis.
A standard 3+3 followed by dose expansion clinical design plus 3 patients with selected dose (the minimum number of patients is 2, the maximum number of patients is 27, and the expected number of patients is 15 assuming 3 patients per 4 dose levels and 3 additional patients with the selected dose) will be used.
- Conditions
- Breast Cancer
- Being tested
- pHLIP® ICG NIRF imaging
- Keywords
- MRI, pHLIP® ICG, Imaging, Tumor stage T1-T2, 21-225, SPY-PHI Systems
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pHLIP® ICG NIRF imagingDiagnostic test
Pre-operative research MRI will be performed 1-3 weeks prior to the surgery. single pHLIP® ICG injection will be administered i.v. by a radiologist on the protocol one day prior to scheduled surgery on the occasion of presurgical localization (12-36 hours prior to the surgery).
In Phase I, we propose to investigate 4 different doses:
Dose level 1 = 0.04 mg/kg Dose level 2 = 0.075 mg/kg Dose level 3 = 0.15 mg/kg Dose level 4 = 0.30 mg/kg
In Phase IIa, the researchers propose to administer selected in Phase I dose of pHLIP® ICG. In Phase IIa, the researchers propose to administer pHLIP® ICG at DL2, DL3 or DL4 at different time points prior to surgery ranging from 12-110 hours, with targeted enrollment of 12 patients. Next, the selected optimal dose and timing will be used with targeted enrollment of 28 patients. The total number of subjects in Phase IIa study is 40.
| Study group | Role | What they receive |
|---|---|---|
| MRI and pHLIP® ICG | Experimental | All study participants in Phase I will receive pre-operative MRI and mpMRI scans, a pre-operative injection of pHLIP ICG, and NIRF imaging during surgery (intra-operatively). During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis. Receives: Diagnostic Test: pHLIP® ICG NIRF imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-limiting toxicity (DLT)
is defined as a clinically significant adverse event recorded within 3 hours after pHLIP® ICG administration or an abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, surgery, or concomitant medications, and meets the NCI common terminology criteria that are CTCAE Grade 3 or 4.
Measured: 15 days post pHLIP® ICG injection
Concordance between the absence of optical signal and histopathological confirmation of absence of malignancy. (Phase II)
Each lesion will be classified as positive or negative based on imaging and compared against histopathology as the gold standard.
Measured: 1 year
Visualization of a lesion with pHLIP® ICG (Phase II)
The visualization of a lesion with pHLIP® ICG NIRF (Likert score is ≥1) will be considered positive for malignancy. No visualization of a lesion or visualization at the background level (Likert score is 0) with pHLIP® ICG NIRF will be considered negative for malignancy.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start19 Nov 2021
- Primary completionNov 2027 (estimated)
- Study completionNov 2027 (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.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Stryker Instruments, pHLIP Inc.
- Responsible party
- Sponsor
- Investigators
- Giacomo Montagna, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05130801
- Sponsor's protocol ID
- 21-225
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2021
- Last updated
- 11 Sep 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
- ClinicalTrials.gov ID
- NCT05130801
- Acronym / sponsor ID
- 21-225
- Conditions
- Breast Cancer
- Keywords
- MRI, pHLIP® ICG, Imaging, Tumor stage T1-T2, 21-225, SPY-PHI Systems
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Stryker Instruments, pHLIP Inc.
- Study start
- 19 Nov 2021 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 23 Nov 2021 (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 this study is to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to see the tumor and nearby tissues that contain cancer cells more clearly and remove them completely.
During the Phase IIa part of this study, the safe dose of pHLIP ICG will be used that makes it easy for the surgeon to see the tumor and the nearby tissues and structures that may contain cancer cells. This study is the first to test pHLIP ICG in people, and the first to test the use of pHLIP ICG with mpMRI and NIRF imaging in surgery for breast cancer.
Detailed description
his protocol involves performing first-in-human imaging with pHLIP® ICG in consecutive patients with newly diagnosed primary BC (tumor stage T1-T2 with or without lymph node metastases) undergoing breast conserving treatment at MSK. All imaging will be obtained either at MRI staging before surgery and during definite surgical treatment; no additional invasive procedures will be necessary.
The information collected in the phase I part of this study will not be used for diagnostic purposes, and neither will the information be used to assess the patients' response to therapy nor adjust the clinical management of the patient.
During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis.
A standard 3+3 followed by dose expansion clinical design plus 3 patients with selected dose (the minimum number of patients is 2, the maximum number of patients is 27, and the expected number of patients is 15 assuming 3 patients per 4 dose levels and 3 additional patients with the selected dose) will be used.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI and pHLIP® ICG | Experimental | Diagnostic Test: pHLIP® ICG NIRF imagingAll study participants in Phase I will receive pre-operative MRI and mpMRI scans, a pre-operative injection of pHLIP ICG, and NIRF imaging during surgery (intra-operatively). During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or greater
- Biopsy proven primary breast malignancy (BI-RADS 6)
- Tumor stage Tis, T1 and T2, lesion size > 1 cm
- Primary surgical treatment with breast conservation
- No previous treatment
Key exclusion criteria (6 listed)
- Life expectancy < 3 months
- Pregnancy or lactation
- Known metastatic liver disease, hepatic neoplasms (benign and malignant), biliary atresia, chronic liver disease (CLD) and cirrhosis.
- Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I)
- Known hypersensitivity to indocyanine green.
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 |
|---|---|---|
| pHLIP® ICG NIRF imagingPre-operative research MRI will be performed 1-3 weeks prior to the surgery. single pHLIP® ICG injection will be administered i.v. by a radiologist on the protocol one day prior to scheduled surgery on the occasion of presurgical localization (12-36 hours prior to the surgery). In Phase I, we propose to investigate 4 different doses: Dose level 1 = 0.04 mg/kg Dose level 2 = 0.075 mg/kg Dose level 3 = 0.15 mg/kg Dose level 4 = 0.30 mg/kg In Phase IIa, the researchers propose to administer selected in Phase I dose of pHLIP® ICG. In Phase IIa, the researchers propose to administer pHLIP® ICG at DL2, DL3 or DL4 at different time points prior to surgery ranging from 12-110 hours, with targeted enrollment of 12 patients. Next, the selected optimal dose and timing will be used with targeted enrollment of 28 patients. The total number of subjects in Phase IIa study is 40. | Diagnostic test | MRI and pHLIP® ICG |
Primary outcome
Dose-limiting toxicity (DLT)
Time frame: 15 days post pHLIP® ICG injection
is defined as a clinically significant adverse event recorded within 3 hours after pHLIP® ICG administration or an abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, surgery, or concomitant medications, and meets the NCI common terminology criteria that are CTCAE Grade 3 or 4.
Concordance between the absence of optical signal and histopathological confirmation of absence of malignancy. (Phase II)
Time frame: 1 year
Each lesion will be classified as positive or negative based on imaging and compared against histopathology as the gold standard.
Visualization of a lesion with pHLIP® ICG (Phase II)
Time frame: up to 6 months
The visualization of a lesion with pHLIP® ICG NIRF (Likert score is ≥1) will be considered positive for malignancy. No visualization of a lesion or visualization at the background level (Likert score is 0) with pHLIP® ICG NIRF will be considered negative for malignancy.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Monica Morrow, MD contact
Giacomo Montagna, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing pHLIP® ICG NIRF imaging in people with Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 2 sites 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 6 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Giacomo Montagna, MD (646-888-6891, montagng@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-limiting toxicity (DLT) (time frame: 15 days post pHLIP® ICG injection). The study lists 3 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 11 Sep 2026.