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LS301 Imaging Agent for Breast Cancer

Phase 1 & 2

Recruiting

Research Sponsored by Integro Theranostics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

DCIS (whether or not undergoing planned SLNB) or patients with Stage I-II, primary invasive carcinoma of the breast undergoing SLNB for which the patient's primary surgical treatment is single breast partial mastectomy.

ECOG performance status of 0 to 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 hours

Awards & highlights

Study Summary

This trial tests safety, effectiveness, and how the body processes a new imaging agent given to women having breast cancer surgery. Safety is top priority.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Potential side effects are not detailed but may include reactions similar to other agents used in the study such as indocyanine green (ICG), which can cause allergic reactions. The safety profile will be closely monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have early-stage breast cancer and am having or had a partial mastectomy.

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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

AUCinf

AUClast

Adverse Events

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: LS301-ITExperimental Treatment4 Interventions

LS301-IT will be adminstered by IV injection

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Integro TheranosticsLead Sponsor

Dan ThompsonStudy DirectorIntegro Theranostics

Media Library

LS301-IT Clinical Trial Eligibility Overview. Trial Name: NCT05900986 — Phase 1 & 2

Breast Cancer Research Study Groups: LS301-IT

Breast Cancer Clinical Trial 2023: LS301-IT Highlights & Side Effects. Trial Name: NCT05900986 — Phase 1 & 2

LS301-IT 2023 Treatment Timeline for Medical Study. Trial Name: NCT05900986 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the age limit for participants in this study restricted to under thirty years of age?

"To qualify for this clinical trial, the patient must be between 18 and 80 years of age. There are a total of 135 trials designed specifically for those under 18 while 4880 cater to individuals over 65."

Answered by AI

Does this medical trial have any prerequisites for new participants?

"For eligibility to this study, individuals must have been diagnosed with breast cancer and have attained the age of majority. Approximately 100 people are required for successful enrollment."

Answered by AI

Is this research effort currently accepting new participants?

"The clinical trial, listed on clinicaltrials.gov and first posted June 1st 2023, is no longer recruiting patients at this time. However, there are still 4999 other studies actively searching for volunteers to participate in groundbreaking medical research."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer

2023. "LS301-IT in Partial Mastectomy and Sentinel Lymph Node Biopsy (SLNB) for DCIS or Stage I-II Primary Invasive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05900986.

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