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Lymph Node Tattoo Marking for Breast Cancer
N/A
Waitlist Available
Led By Leah H Portnow, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to completion of surgery up to 1 year
Awards & highlights
Study Summary
This trial is investigating if SpotTM ink can help surgeons retrieve sampled lymph nodes as well or better than the standard clip and radioseed guidance method.
Who is the study for?
This trial is for adults with new or suspected breast cancer and suspicious lymph nodes, who can undergo imaging and surgery. They must be in good enough health to perform daily activities (ECOG ≤2). Pregnant women may join. Excluded are those allergic to SpotTM ink components, with certain psychiatric conditions, existing tattoos that could interfere, or uncontrolled illnesses.Check my eligibility
What is being tested?
The study tests if SpotTM tattoo ink can better identify sampled lymph nodes during surgery compared to the standard clip and radioseed guidance methods after a core needle biopsy or fine needle aspiration of breast tissue.See study design
What are the potential side effects?
Potential side effects were not explicitly listed but may include reactions similar to other tattoo inks such as skin irritation at the injection site or allergic responses.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to completion of surgery up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to completion of surgery up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retrieval Rate
Secondary outcome measures
Cost savings
Trial Design
1Treatment groups
Experimental Treatment
Group I: Lymph Node SpotTM TattooExperimental Treatment1 Intervention
Spot™ ink tattooing will be administered once prior to surgery.
Initial test set of participants with previous sampled lymph nodes positive for metastasis will have SpotTM ink administered at time of standard of care pre-surgery radioseed localization.
A feasibility set of participants will have SpotTM ink administered at time standard of care lymph nodes sampling.
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Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,938 Total Patients Enrolled
141 Trials studying Breast Cancer
22,607 Patients Enrolled for Breast Cancer
Leah H Portnow, MDPrincipal InvestigatorBrigham and Women's Hospital
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had allergic reactions to substances similar to Spot™ ink.You have tattoos on your chest or arm on the same side as your cancer, which could make it hard to see important areas during the study.You have recently been diagnosed with breast cancer or have suspicious imaging results indicating breast cancer.You must be healthy enough to have breast imaging and surgery, with a performance status score of 2 or less.You have a history of heart problems or symptoms, or have been treated with certain medications that can affect the heart. Your doctor will check how well your heart is working to see if you can join the trial.You must be at least 18 years old to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Lymph Node SpotTM Tattoo
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants being accepted for this research project presently?
"According to the information on clinicaltrials.gov, enrollment for this trial is still open; it was initially posted on December 29th 2021 and last revised on January 31st 2022."
Answered by AI
How many people have volunteered for this medical experiment?
"Affirmative. The clinical trial is still recruiting, according to data on clinicialtrials.gov. It was initially posted in late December 2021 and the most recent update occured at the end of January 2022; Furthermore, 80 participants are being sought out from one medical facility for this study."
Answered by AI
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