A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT05130801|
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : November 23, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Diagnostic Test: pHLIP® ICG NIRF imaging||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer|
|Actual Study Start Date :||November 19, 2021|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||November 2023|
Experimental: MRI and pHLIP® ICG
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.
Diagnostic Test: pHLIP® ICG NIRF imaging
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130801
|Contact: Katja Pinker-Domenig, MD, PhDfirstname.lastname@example.org|
|Contact: Monica Morrow, MD||646-888-5350|
|United States, New York|
|Memorial Sloan Kettering Cancer Center (All Protocol Activities)||Recruiting|
|New York, New York, United States, 10065|
|Contact: Katja Pinker-Domenig, MD, PhD 646-888-5470|
|Principal Investigator:||Katja Pinker-Domenig, MD, PhD||Memorial Sloan Kettering Cancer Center|