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Sentinel Lymph Node Biopsy for Breast Cancer (SHINE Trial)

Q: Is participation in this experiment open to geriatric individuals?

This clinical trial focuses on patients between the ages of 18 and 80. For those below 18 years old, there are 72 trials available while 2632 studies are accessible for people beyond 65 years old.

Q: How might I become part of this research endeavor?

This clinical trial is seeking 100 participants aged between 18 and 80 with a diagnosis of <a href="https://www.withpower.com/clinical-trials/breast-cancer">breast cancer</a>.

Q: How many people have been enrolled in this clinical investigation?

Affirmative, clinicaltrials.gov details that this research is still recruiting participants. It was first posted on November 1st 2023 and has been updated as recently 13th October 2023. One hundred volunteers are required for the trial across one location.

Q: Are there any vacancies in this research endeavor for potential subjects?

This clinical research is still recruiting, as evidenced by the details on clinicaltrials.gov. The trial was created and last updated on November 1st 2023 and October 13th 2023 respectively.

N/A

Recruiting

Research Sponsored by University Health Network, Toronto

Eligibility Criteria Checklist

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

Must have

Eastern Cooperative Oncology Group (ECOG) < 2

Adults ≥ 18 and ≤ 80

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

SHINE Trial Summary

This trial tests a new technique for sentinel lymph node biopsy to help diagnose breast cancer after chemotherapy.

Who is the study for?

The SHINE trial is for adults aged 18-80 with Stage I-III invasive breast cancer who've had chemo and are set for a sentinel lymph node biopsy (SLNB). They must be in good physical condition, not allergic to ICG/iodine, able to consent, and literate in English. It's not for those with severe health issues, advanced breast cancer stages unsuitable for SLNB, or past surgery/radiotherapy on the affected area.Check my eligibility

What is being tested?

This study tests if using Indocyanine green (ICG) to guide SLNB during surgery is as accurate as the standard method using blue dye and radiotracer. Patients will have both techniques used during their operation to compare results. The trial also looks at patient comfort and surgical outcomes through questionnaires.See study design

What are the potential side effects?

Potential side effects may include reactions related to ICG injection such as allergy symptoms or skin staining. There might also be general risks associated with biopsies like pain, infection, or swelling at the injection site.

SHINE Trial Eligibility Criteria

Inclusion Criteria

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

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I can do all my daily activities without help.

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I am between 18 and 80 years old.

SHINE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Non-inferiority of ICG SLNB compared to dual-tracer SLNB in post-neoadjuvant chemotherapy treated breast cancer patients.

Secondary outcome measures

Complications/safety

Patient reported outcome measures - Breast-Q

Patient reported outcome measures - FACT-B+4

+1 more

Other outcome measures

Budget impact analysis

SHINE Trial Design

1Treatment groups

Experimental Treatment

Group I: ICG-SLNBExperimental Treatment1 Intervention

This is a prospective within-patient clinical study to assess the accuracy of ICG SLNB compared to standard dual-tracer SLNB in breast cancer patients treated with neoadjuvant chemotherapy. For SLNB, triple localization of the sentinel lymph nodes using blue dye, Tc-99m and ICG will be utilized in each patient.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor

1,476 Previous Clinical Trials

485,080 Total Patients Enrolled

53 Trials studying Breast Cancer

29,454 Patients Enrolled for Breast Cancer

Frequently Asked Questions

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

Is participation in this experiment open to geriatric individuals?

"This clinical trial focuses on patients between the ages of 18 and 80. For those below 18 years old, there are 72 trials available while 2632 studies are accessible for people beyond 65 years old."

Answered by AI

How might I become part of this research endeavor?

"This clinical trial is seeking 100 participants aged between 18 and 80 with a diagnosis of breast cancer."

Answered by AI

How many people have been enrolled in this clinical investigation?

"Affirmative, clinicaltrials.gov details that this research is still recruiting participants. It was first posted on November 1st 2023 and has been updated as recently 13th October 2023. One hundred volunteers are required for the trial across one location."

Answered by AI

Are there any vacancies in this research endeavor for potential subjects?

"This clinical research is still recruiting, as evidenced by the details on clinicaltrials.gov. The trial was created and last updated on November 1st 2023 and October 13th 2023 respectively."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)

2024. "Sentinel lympH Node Biopsy With Indocyanine Green in Breast Cancer After NEoadjuvant Chemotherapy (SHINE)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085274.