LS301 Imaging Agent for Breast Cancer
Recruiting in Palo Alto (17 mi)
+10 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: Integro Theranostics
Disqualifiers: Bilateral lumpectomies, Anaphylactic reactions, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests a special dye called LS301-IT that helps surgeons see breast cancer cells more clearly during surgery. It targets women with early-stage breast cancer undergoing partial mastectomy. The dye makes cancer cells glow under a special light, aiding in more precise removal.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you have had prior chemotherapy, endocrine therapy, or biologic therapy for your current breast cancer, you may not be eligible to participate.
What data supports the effectiveness of the LS301-IT treatment for breast cancer?
The research highlights the potential of molecular imaging, like PET and SPECT, to help select and monitor breast cancer treatments by identifying specific tumor characteristics. This suggests that imaging agents like LS301 could be useful in assessing breast cancer and guiding treatment decisions.
12345How is the LS301 Imaging Agent for Breast Cancer different from other treatments?
The LS301 Imaging Agent is unique because it is a multimodal imaging agent that combines both radioactive and fluorescent labels, allowing for whole-body and intraoperative imaging with a single administration. This dual-labeling provides complementary diagnostic information that can guide tumor removal, which is not typically available with standard imaging methods.
16789Eligibility Criteria
This trial is for women having partial mastectomy for DCIS or Stage I-II primary invasive breast cancer, including those planning SLNB. Participants should be in good general health with an ECOG performance status of 0 to 2. It's not suitable for those who've had recent breast surgery, chest radiation therapy, prior cancer treatments for the current diagnosis, or severe drug allergies.Inclusion Criteria
I have early-stage breast cancer and am having or had a partial mastectomy.
I can take care of myself and am up and about more than half of my waking hours.
Exclusion Criteria
I have had chemotherapy, hormone therapy, or biological therapy for my current breast cancer.
I have had lumpectomies or partial mastectomies on both breasts.
ICG imaging agents will not be used before my breast surgery.
+4 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Phase 1b: Dose Finding
Dose finding (escalation/de-escalation) and dose timing adjustment for LS301-IT
4-6 weeks
Multiple visits for dose adjustment
Phase 2a: Expanded Sample Size
Expanded sample size based on acceptable dosing regimen determined in Phase 1b
6-8 weeks
Visits for LS301-IT administration and surgery
Phase 2b: Surgical Decision Making
Surgeon makes additional surgical decisions based on fluorescence imaging findings during surgery
Dependent on surgical schedule
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
2 visits (in-person)
Participant Groups
The study tests different doses of LS301-IT, a new imaging agent given by IV before surgery to see how safe and effective it is at highlighting cancerous tissue during partial mastectomy and SLNB procedures in patients with certain types of breast cancer.
1Treatment groups
Experimental Treatment
Group I: LS301-ITExperimental Treatment4 Interventions
LS301-IT will be administered by IV injection
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Integro Theranostics Research Site #2Bronx, NY
Integro Theranostics Research Site #1Scottsdale, AZ
Integro Theranostics Research Site #12Washington, United States
Integro Theranostics Research Site #9Weston, FL
More Trial Locations
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Who Is Running the Clinical Trial?
Integro TheranosticsLead Sponsor
References
Molecular imaging of breast cancer. [2016]Molecular imaging of breast cancer can potentially be used for breast cancer screening, staging, restaging, response evaluation and guiding therapies. Techniques for molecular breast cancer imaging include magnetic resonance imaging (MRI), optical imaging, and radionuclide imaging with positron emission tomography (PET) or single photon emission computed tomography (SPECT). This review focuses on PET and SPECT imaging which can provide sensitive serial non invasive information of tumor characteristics. Most clinical data are gathered on the visualization of general processes such as glucose metabolism with the PET-tracer [(18)F]fluorodeoxyglucose (FDG) and DNA synthesis with [18F]fluoro-L-thymidine (FLT). Increasingly more breast cancer specific targets are imaged such as the estrogen receptor (ER), growth factors and growth factor receptors. Imaging of the ER with the PET tracer 16-alpha-[(18)F]fluoro-17-beta-estradiol (FES) has shown a good correlation between FES tumor uptake and ER density. (111)In-trastuzumab SPECT to image the human epidermal growth factor receptor 2 (HER2) showed that in most patients with metastatic HER2 overexpressing disease more lesions were detected than with conventional staging procedures. The PET tracer (89)Zr-trastuzumab showed excellent, quantifiable, and specific tumor uptake. (111)In-bevacizumab for SPECT and (89)Zr-bevacizumab for PET-imaging have been developed for vascular endothelial growth factor (VEGF) imaging as an angiogenic marker. Lastly, tracers for the receptors EGFR, IGF-1R, PDGF-betaR and the ligand TGFbeta are under development. Although molecular imaging of breast cancer is still not commonly used in daily clinical practice, its application portfolio is expanding rapidly.
Steroid Receptor Imaging in Breast Cancer. [2016]A high proportion of breast cancers express estrogen and progesterone receptors. This can guide oncologists on hormonal therapy's suitability for breast cancer. With second-line hormonal therapy agents such as aromatase inhibitors and pure antagonists, imaging methods could be critical in assessing the presence of estrogen or progesterone receptors. Several radiopharmaceuticals were developed for imaging of estrogen or progesterone receptors. Estrogen receptor imaging could play a useful role in predicting the response of breast cancer to hormone therapy. Large-scale trials will determine the respective roles of tamoxifen, aromatase inhibitors, and fulvestrant, and the optimal drug administration sequence. Early noninvasive identification of patients who will likely fail all forms of hormonal therapy could be achieved by positron emission tomography.
Tumor-receptor imaging in breast cancer: a tool for patient selection and response monitoring. [2019]Breast cancer is a heterogeneous disease that can be subdivided into different groups, based on gene expression profiles or clinicopathological characteristics such as estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) expression. The expression of these receptors has both prognostic and predictive value. To improve breast cancer treatment, accurate methods for patient selection and response monitoring are required. One way to achieve this is by using molecular imaging, which can be used to measure the expression and accessibility of tumor-associated antigens in vivo, without the need of invasive biopsies. This review will focus on tumor-receptor imaging for currently approved targeted therapies and discuss the potential role of molecular imaging in the development of new therapeutic agents in breast cancer. Progress has been made in radionuclide imaging of ER, PR, HER2 and epidermal growth factor receptor (EGFR) expression, which can be used for treatment selection and response prediction to endocrine and other targeted therapy. Moreover, clinical studies have shown the feasibility for molecular imaging of the angiogenic pathway exploiting the expression of antigens closely associated with angiogenesis, such as αvβ3 and VEGF. As proof of concept has been established, further research should be directed towards validation of the imaging methods and the impact on patient management.
Clinical Evaluation of Nuclear Imaging Agents in Breast Cancer. [2022]Precision medicine is the customization of therapy for specific groups of patients using genetic or molecular profiling. Noninvasive imaging is one strategy for molecular profiling and is the focus of this review. The combination of imaging and therapy for precision medicine gave rise to the field of theranostics. In breast cancer, the detection and quantification of therapeutic targets can help assess their heterogeneity, especially in metastatic disease, and may help guide clinical decisions for targeted treatments. Positron emission tomography (PET) or single-photon emission tomography (SPECT) imaging has the potential to play an important role in the molecular profiling of therapeutic targets in vivo for the selection of patients who are likely to respond to corresponding targeted therapy. In this review, we discuss the state-of-the-art nuclear imaging agents in clinical research for breast cancer. We reviewed 17 clinical studies on PET or SPECT agents that target 10 different receptors in breast cancer. We also discuss the limitations of the study designs and of the imaging agents in these studies. Finally, we offer our perspective on which imaging agents have the highest potential to be used in clinical practice in the future.
Detection of Treatment Response in Triple-Negative Breast Tumors to Paclitaxel Using MRI Cell Size Imaging. [2023]Breast cancer treatment response evaluation using the response evaluation criteria in solid tumors (RECIST) guidelines, based on tumor volume changes, has limitations, prompting interest in novel imaging markers for accurate therapeutic effect determination.
Molecular breast imaging with gamma emitters. [2016]Following a diagnosis of breast cancer (BC), the early detection of local recurrence is important to define appropriate therapeutic strategies and increase the chances of a cure. In fact, despite major progress in surgical treatment, radiotherapy, and chemotherapy protocols, tumor recurrence is still a major problem. Moreover, the diagnosis of recurrence with conventional imaging methods can be difficult as a result of the presence of scar tissue. Molecular breast imaging (MBI) with gamma-ray emitting radiotracers may be very useful in this clinical setting, because it is not affected by the post-therapy morphologic changes. This review summarises the applications of 99mTc-sestamibi and 99mTc-tetrofosmin, the two most employed gamma emitter radiopharmaceuticals for MBI, in the diagnosis of local disease recurrence in patients with BC. The main limitation of MBI using conventional gamma-cameras is the low sensitivity for small BCs. The recent development of hybrid single photon emission computed tomography/computed tomography devices and especially of high-resolution specific breast cameras can improve the detection rate of sub-centimetric malignant lesions. Nevertheless, probably only the large availability of dedicated cameras will allow the clinical acceptance of MBI as useful complementary diagnostic technique in BC recurrence. The possible role of MBI with specific cameras in monitoring the local response of BC to neoadjuvant chemotherapy is also briefly discussed.
Sentinel Lymph Node Biopsy in Breast Cancer with 99mTc-Tilmanocept: A Multicenter Study on Real-Life Use of a Novel Tracer. [2021]99mTc-tilmanocept is a novel radiopharmaceutical for sentinel lymph node (SLN) biopsy in breast cancer. Our aim was to describe results with 99mTc-tilmanocept in a heterogeneous group of breast cancer patients scheduled for SLN biopsy. Methods: Radiotracer preparation followed the manufacturer's indications. Local protocols for SLN detection within 9 participant centers were not changed for the entire duration of the study. In total, 344 patients with T1-T4, N0-N2 breast cancer (352 lesions) were included. Superficial (intradermal or periareolar) or deep (peritumoral or intratumoral) injections were performed. The doses were adjusted depending on the scheduled time for surgery. Results: Lymphoscintigraphy was able to depict at least 1 SLN in 339 of 352 breast lesions (96.3%), and the intraoperative SLN detection rate reached 97.2%. On univariable analysis, SLN detection rates did not differ by age, clinical T or N stage, tumor location, histologic subtype, or prior neoadjuvant therapy. Lymphoscintigraphy showed higher SLN detection in patients with a normal weight (body mass index < 25) than in those who were overweight or obese (body mass index ≥ 25), at 99.2% versus 94.6%, respectively (P = 0.031). The proportion of patients with preoperative lymphoscintigraphic detection or excised SLNs was higher with superficial than deep injections. Reinjected cases were significantly lower when superficial injection was chosen first (P < 0.001). Injection site and the tumor markers human epidermal growth factor receptor 2 and estrogen receptor had an impact on preoperative SLN visualization and intraoperative localization. In 80 cases, SLN biopsy resulted in a positive lymph node. During a mean follow-up of 19 mo, no axillary recurrences were observed. Conclusion: Whatever the protocol, 99mTc-tilmanocept showed good results in a heterogeneous breast cancer population, although the best results were achieved when a superficial injection was chosen.
LyP-1 Conjugated Nanoparticles for Magnetic Resonance Imaging of Triple Negative Breast Cancer. [2019]Label="PURPOSE">Triple-negative breast cancer (TNBC) does not express estrogen receptor, progesterone receptor, or Her2/neu. Both diagnosis and treatment of TNBC remain a clinical challenge. LyP-1 is a cyclic 9 amino acid peptide that can bind to breast cancer cells. The goal of this study was to design and characterize LyP-1 conjugated to fluorescent iron oxide nanoparticles (LyP-1-Fe3O4-Cy5.5) as a contrast agent for improved and specific magnetic resonance imaging (MRI) in a preclinical model of TNBC.
Advances in the Development of Multimodal Imaging Agents for Nuclear/Near-infrared Fluorescence Imaging. [2019]Multimodal imaging agents were first introduced a decade ago and consist of a targeting moiety that is dual-labeled with radioactive and fluorescent contrast. These compounds allow whole-body and intraoperative imaging to be performed through administration of a single agent and provide complementary diagnostic information that can be used to guide tumor resection. Since their initial evaluation, interest in dual-labeled agents has continued to grow and their design has subsequently evolved alongside the development of novel chelating agents, improved fluorophores, and highly selective coupling techniques for bioconjugate formation. In this review, will discuss how changes in the labeling components and schemes for multimodal agent development have impacted imaging performance and will focus on antibody- and peptide-based agents as models for dual labeling. We will also describe the growing role of modular dual labeling strategies as well as direct labeling methods using radiohalogens.