SpotTM Tattoo Ink for Breast Cancer
Brigham and Women's Hospital, Boston, MA
Targeting 2 different conditionsSpotTM Tattoo InkN/ARecruitingLed by Leah H Portnow, MDResearch Sponsored by Dana-Farber Cancer InstituteEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women who are pregnant or lactating are eligible as Spot™ ink is placed focally in the axillary lymph node and breast tissues.
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upenrollment to completion of surgery up to 1 year
Awards & highlights
No Placebo-Only Group
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.
Eligible Conditions
- Breast Cancer
- Metastasis
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
Women who are pregnant or breastfeeding cannot participate as the study involves placing ink in the breast tissue and lymph nodes.
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
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
1,049 Previous Clinical Trials
765,001 Total Patients Enrolled
138 Trials studying Breast Cancer
22,389 Patients Enrolled for Breast Cancer
Leah H Portnow, MDPrincipal Investigator
Brigham and Women's HospitalMedia Library
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