LS301 Imaging Agent for Breast Cancer

Recruiting at 10 trial 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. ^{1 2 3 4 5}

How 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. ^{1 6 7 8 9}

Research Team

Dan Thompson

Principal Investigator

Integro Theranostics

Eligibility 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.

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)

Treatment Details

Interventions

• LS301-IT (Fluorescence Imaging Agent)

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Molecular imaging of breast cancer. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Steroid Receptor Imaging in Breast Cancer. [2016]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Tumor-receptor imaging in breast cancer: a tool for patient selection and response monitoring. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Clinical Evaluation of Nuclear Imaging Agents in Breast Cancer. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Detection of Treatment Response in Triple-Negative Breast Tumors to Paclitaxel Using MRI Cell Size Imaging. [2023]

6. Italy pubmed.ncbi.nlm.nih.gov

Molecular breast imaging with gamma emitters. [2016]

7. United States 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. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

LyP-1 Conjugated Nanoparticles for Magnetic Resonance Imaging of Triple Negative Breast Cancer. [2019]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Advances in the Development of Multimodal Imaging Agents for Nuclear/Near-infrared Fluorescence Imaging. [2019]