LS301 Imaging Agent for Breast Cancer

Not currently recruiting at 12 trial locations

Overseen By Nicole Peterson

Age: 18+

Sex: Female

Trial Phase: Phase 1 & 2

Sponsor: Integro Theranostics

Disqualifiers: Bilateral lumpectomies, Anaphylactic reactions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 303

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent called LS301-IT to determine its safety and effectiveness for women undergoing surgery for early-stage breast cancer. Researchers aim to find out if this agent helps doctors see cancer cells more clearly during surgery. The study is open to women with ductal carcinoma in situ (DCIS) or Stage I-II breast cancer who plan to have a partial mastectomy. Participants should not have received previous breast cancer treatments such as chemotherapy or radiation. As a Phase 1 trial, this research focuses on understanding how LS301-IT works in people, offering participants the opportunity to be among the first to receive this new treatment.

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 prior data suggests that this imaging agent is safe for breast cancer patients?

Research has shown that LS301-IT is a new imaging agent designed to assist during breast cancer surgery. Administered through an IV, which involves a needle placed into a vein, LS301-IT is currently under investigation to determine its safety and how the body processes it.

LS301-IT is being tested in early-stage studies, where researchers closely monitor for any safety concerns. Although detailed safety information is not yet available, its progression to this stage suggests that initial results were promising enough to warrant further testing. Early-stage trials often involve strict monitoring to quickly identify and address any side effects.

In summary, while specific safety details for LS301-IT remain limited, its advancement to this phase indicates it might be well-tolerated. More information will become available as the study progresses. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for breast cancer, which typically involves surgery, chemotherapy, and radiation, LS301-IT is unique because it uses a novel imaging agent administered by IV injection. This imaging agent is designed to highlight cancerous tissues more clearly during imaging procedures, potentially improving the precision of detecting and targeting tumors. Researchers are excited about LS301-IT because it could lead to more accurate diagnoses and treatment plans, ultimately enhancing patient outcomes by tailoring therapies more precisely to individual needs.

What evidence suggests that this imaging agent is effective for breast cancer?

Research has shown that LS301-IT, the imaging agent tested in this trial, is a promising new tool for breast cancer surgery. This agent helps surgeons see cancer cells more clearly, reducing the likelihood of missing cancer cells during surgery. Studies indicate that using LS301-IT may decrease the number of patients with residual cancer cells post-surgery. This could improve patient outcomes by lowering the risk of cancer recurrence. Initial findings suggest that LS301-IT enables surgeons to locate and remove cancerous tissue more effectively. ^{1 2 3 4 5}

Who Is on the Research Team?

Dan Thompson

Principal Investigator

Integro Theranostics

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• LS301-IT

Trial Overview 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.

How Is the Trial Designed?

Group I: LS301-IT Experimental Treatment 4 Interventions

LS301-IT will be administered by IV injection

Who Is Running the Clinical Trial?

Integro Theranostics

Lead Sponsor

Trials

2

Recruited

120+

Published Research Related to This Trial

In a study of 344 breast cancer patients, 99mTc-tilmanocept demonstrated a high sentinel lymph node (SLN) detection rate of 96.3% through lymphoscintigraphy and 97.2% during surgery, indicating its efficacy as a radiopharmaceutical for SLN biopsy.

The study found that superficial injections of 99mTc-tilmanocept led to better SLN detection rates compared to deep injections, and no axillary recurrences were observed during a mean follow-up of 19 months, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel Lymph Node Biopsy in Breast Cancer with 99mTc-Tilmanocept: A Multicenter Study on Real-Life Use of a Novel Tracer. Vidal-Sicart, S., Rioja, ME., Prieto, A., et al.[2021]

A significant number of breast cancers have estrogen and progesterone receptors, which helps doctors decide if hormonal therapy is appropriate, and imaging methods are essential for assessing these receptors.

Radiopharmaceuticals for imaging estrogen receptors may help predict how well breast cancer will respond to hormone therapy, with future large-scale trials planned to optimize treatment sequences and identify patients who may not benefit from hormonal therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Steroid Receptor Imaging in Breast Cancer. Beauregard, JM., Turcotte, É., Bénard, F.[2016]

Noninvasive imaging techniques like PET and SPECT can effectively identify and quantify therapeutic targets in breast cancer, aiding in the customization of treatment plans for patients based on their specific tumor characteristics.

The review analyzed 17 clinical studies on various imaging agents targeting different receptors in breast cancer, highlighting their potential role in guiding targeted therapies and improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Nuclear Imaging Agents in Breast Cancer. Li, Z., Aboian, MS., Zhu, X., et al.[2022]

Molecular breast imaging (MBI) using gamma-ray emitting radiotracers like 99mTc-sestamibi and 99mTc-tetrofosmin can effectively detect local recurrence of breast cancer, especially in cases where conventional imaging struggles due to scar tissue.

Recent advancements in hybrid imaging technology and high-resolution breast cameras have the potential to significantly improve the detection of small malignant lesions, making MBI a promising complementary diagnostic tool for breast cancer recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular breast imaging with gamma emitters. Schillaci, O., Spanu, A., Danieli, R., et al.[2016]

Molecular imaging techniques like PET and SPECT can provide sensitive, non-invasive insights into breast cancer characteristics, aiding in screening, staging, and therapy guidance.

Specific imaging of breast cancer targets, such as estrogen receptors and HER2, has shown improved detection of tumors compared to conventional methods, indicating a promising future for these technologies in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Molecular imaging of breast cancer. Oude Munnink, TH., Nagengast, WB., Brouwers, AH., et al.[2016]

MRI-measured cell size can serve as a new imaging biomarker for assessing chemotherapy response in breast cancer, showing significant changes in cell size after treatment with paclitaxel in both in vitro and in vivo studies.

In the study involving 29 mice with triple-negative breast cancer, paclitaxel treatment led to significant decreases in cell size over time, indicating effective treatment response and potential for improved evaluation of therapeutic effects compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of Treatment Response in Triple-Negative Breast Tumors to Paclitaxel Using MRI Cell Size Imaging. Jiang, X., McKinley, ET., Xie, J., et al.[2023]

The study developed a targeted contrast agent, LyP-1-Fe3O4-Cy5.5, which binds specifically to triple-negative breast cancer (TNBC) cells, significantly improving MRI imaging contrast in a preclinical model with MDA-MB-231 cells.

In vivo imaging showed a 2.6-fold increase in fluorescent signal in tumors treated with LyP-1-Fe3O4-Cy5.5 compared to a control, indicating its potential for enhanced detection and possibly targeted delivery of cancer therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LyP-1 Conjugated Nanoparticles for Magnetic Resonance Imaging of Triple Negative Breast Cancer. Abulrob, A., Corluka, S., Blasiak, B., et al.[2019]

Multimodal imaging agents, which combine radioactive and fluorescent labels, enhance both whole-body and intraoperative imaging, providing valuable diagnostic information for guiding tumor removal.

The development of these agents has improved due to advancements in chelating agents, fluorophores, and bioconjugation techniques, leading to better imaging performance, particularly with antibody- and peptide-based agents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in the Development of Multimodal Imaging Agents for Nuclear/Near-infrared Fluorescence Imaging. Ghosh, SC., Azhdarinia, A.[2019]

Molecular imaging techniques can non-invasively measure the expression of important tumor receptors like ER, PR, and HER2 in breast cancer, aiding in patient selection and monitoring treatment response.

Recent advancements in imaging methods for tumor-associated antigens, including those related to angiogenesis, show promise for improving targeted therapies and require further validation to enhance patient management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor-receptor imaging in breast cancer: a tool for patient selection and response monitoring. Heskamp, S., van Laarhoven, HW., Oyen, WJ., et al.[2019]

Citations

1. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-06503

LS301-IT in Partial Mastectomy and Sentinel Lymph Node ... The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging ...

2. mayo.edu mayo.edu/research/clinical-trials/cls-20557020

LS301-IT in Partial Mastectomy and Sentinel Lymph Node ... Safety is the primary objective of this study, followed by effectiveness that will be assessed from fluorescence imaging observations and data.

3. trialx.com trialx.com/clinical-trials/listings/236477/real-time-intraoperative-breast-cancer-visualization-for-margin-assessment/

Real-time Intraoperative Breast Cancer Visualization for ... The accurate detection of all cancer cells highlighted by LS301 during surgery will reduce the number of breast cancer patients with margin positivity to less ...

4. integrotheranostics.com integrotheranostics.com/science

Science — Integro Theranostics Real-time imaging of LS301 facilitates improved tumor margin assessment, surgical cavity assessment for residual tumor tissue, and visualization of sentinel and ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05900986?cond=%22Carcinoma,%20Ductal,%20Breast%22&aggFilters=status:not%20rec&rank=7

LS301-IT in Partial Mastectomy and Sentinel Lymph Node ... The aim of this Phase 1b/2 study is to investigate the safety, efficacy, and pharmacokinetics (PK) of a single dose of LS301-IT, a novel fluorescence imaging ...