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Lymphoscintigraphy for Breast Cancer
N/A
Recruiting
Led By Faina Nahklis, 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 within 2 years from surgery
Awards & highlights
Study Summary
This trial is testing if Lymphoscintigraphy can help find the sentinel lymph nodes in patients with inflammatory breast cancer.
Who is the study for?
This trial is for women over 18 with Stage III inflammatory breast cancer (IBC), which includes rapid onset symptoms, redness and swelling of the breast. They must have a performance status that allows daily activity and be able to consent to study procedures. Those who've started pre-operative therapy or have metastatic cancer, positive contralateral axillary nodes, or contralateral invasive breast cancer are excluded.Check my eligibility
What is being tested?
The study tests if Lymphoscintigraphy can effectively show lymph drainage patterns in IBC patients and identify sentinel lymph nodes during surgery using blue dye and radioactive substances. It also examines the occurrence of lymphedema post-surgery and overall outcomes for IBC patients.See study design
What are the potential side effects?
Potential side effects may include discomfort from imaging procedures, allergic reactions to dyes or radioactive materials used, risks associated with biopsy such as bleeding or infection, and possible development of lymphedema after node surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ within 2 years from surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 2 years from surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Sentinel Lymph Node (SLN) identification rate
Secondary outcome measures
Disease-free survival (DFS)
Distant recurrence-free survival rate (DRFS)
Local-regional recurrence free survival rate (LRRFS)
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Sentinal Node IdentificationExperimental Treatment1 Intervention
Within standard of care treatment for inflammatory breast cancer, participants will undergo a series of Lymphoscintigraphies: an imaging procedure to determine where their lymphatic system drains from their breast.
Prior to neoadjuvant chemotherapy
Day before surgery
These two imaging studies will be compared and the information used during participant's surgery to perform the sentinel node biopsy procedure.
During surgery participants will have a blue dye injected to affected breast to map drainage and identify sentinal nodes. The sentinal nodes will be removed first, followed by standard of care procedure to remove all axillary lymph nodes.
After surgery, a small amount of tissue from the tumor removed during surgery will be evaluated.
Participants will complete a Lymphedema Questionnaire after each Lymphoscintigraphy then every 6 months for 2 years post surgery.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lymphoscintigraphy
2012
Completed Phase 2
~530
Find a Location
Who is running the clinical trial?
Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,930 Total Patients Enrolled
141 Trials studying Breast Cancer
22,567 Patients Enrolled for Breast Cancer
Faina Nahklis, MDPrincipal InvestigatorDana-Farber Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have cancer in the lymph nodes under my opposite arm as confirmed by imaging and biopsy.You have stage III inflammatory breast cancer, which is a specific type of cancer with rapid onset symptoms and specific physical signs in the breast.I do not have stage IV breast cancer and no signs of cancer spread were found in my initial tests.I have not started any treatment before signing up for this trial.
Research Study Groups:
This trial has the following groups:- Group 1: Sentinal Node Identification
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.
What is the approximate size of the participant pool for this clinical trial?
"Affirmative. Clinicaltrials.gov data reveals that this clinical trial is presently accepting participants, the first post of which was on June 2nd 2021 and last modified July 4th 2022. The study is hoping to enroll 50 patients at a single site."
Answered by AI
Is the enrollment phase of this trial still open?
"Affirmative. Clinicaltrials.gov data points to this trial as actively recruiting participants, having been initially posted on June 2nd 2021 and recently updated on July 4th 2022. A total of 50 patients will be enrolled at a single medical site."
Answered by AI
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