Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329089
Status:
RECRUITING
Last Update Posted:
2024-03-25
First Post:
2024-03-18
Brief Title:
Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer
Sponsor:
Hospital Clinic of Barcelona
Organization:
Hospital Clinic of Barcelona
Study Overview
Official Title:
RENATA Study Reoperative Sentinel Lymph Node Biopsy in Patients With Recurrent Ipsilateral Breast Cancer and Prior Axillary Surgical Techniques and Approaches
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RENATA
Brief Summary:
The goal of this observational study is to assess the effectiveness of sentinel lymph node biopsy as a treatment approach for patients with recurrent breast cancer on the same side as previous surgeries The main questions it aims to answer are
What is the rate of identification of the sentinel lymph node and how does it vary among patients with different histories of axillary surgeries
How can we describe and understand the drainage pathways including those from the armpit on the same side as the cancer the area near the breastbone and the opposite armpit
Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer They will also receive standard treatments including surgery and adjuvant therapies as recommended by their healthcare team
What is the rate of identification of the sentinel lymph node and how does it vary among patients with different histories of axillary surgeries
How can we describe and understand the drainage pathways including those from the armpit on the same side as the cancer the area near the breastbone and the opposite armpit
Participants will undergo sentinel lymph node biopsy as part of their treatment for recurrent breast cancer They will also receive standard treatments including surgery and adjuvant therapies as recommended by their healthcare team
Detailed Description:
Prospective multicentric collection will be conducted for all patients diagnosed with ipsilateral recurrent breast cancer who meet the criteria and are eligible for surgery and who wish to participate in the study Additional examinations and treatments will be performed according to standard clinical practice Tests not included in routine practice will not be conducted
Suspicion of axillary involvement will be ruled out using ultrasound or magnetic resonance imaging as well as distant metastasis with standard staging studies bone scintigraphycomputed tomography of the thorax abdomen and pelvis
Lymphatic mapping will be performed according to each hospitals protocol similar to lymphatic mapping in primary breast cancer The radiotracerdye will be injected according to each centers standard practice peritumoral intratumoral intradermal or periareolar in the quadrant of the tumor the day before or on the day of surgery by Nuclear MedicineRadiology Lymphoscintigraphy will be performed and the detected sentinel lymph nodes SLNs will be marked on the skin with inkmarker In cases where the SLN is not visualized a second dose of radiotracer may be administered
If there is no drainage from the SLN and no prior lymphadenectomy LA additional axillary surgery will not be performed If there is no drainage from the SLN and no prior LA consideration will be given to performing lymphadenectomy according to each centers protocol
During surgery SLNs will be identified using a gamma probe andor dye with assistance from the nuclear medicine service Between one and three SLNs will be removed whether drainage is in the ipsilateral axilla internal mammary or contralateral axilla They will be sent to Pathology for intraoperative or deferred examination by One-Step Nucleic Acid Amplification OSNA or conventional technique
If infiltration is found in any of the axillary SLNs isolated tumor cells micrometastasis or macrometastasis axillary surgery will be completed with a lymphadenectomy including levels I and II of Berg If infiltration is found in internal mammary SLNs and not in axillary SLNs irradiation of the internal mammary chain will be performed recommended dose of 50 Gy without completing the LA If contralateral axillary SLNs are affected further treatment will be decided by consensus in the subsequent treatment committee
A wound care visit with a specialized breast unit nurse will be scheduled for the week after surgery to assess postoperative complications and an outpatient consultation with Gynecology will be scheduled for 3 weeks after surgery for further evaluation
Adjuvant treatment will be administered according to consensus in the hospitals multidisciplinary committee following standard practice
Follow-up will be conducted in outpatient consultations with GynecologyMedical OncologyRadiation Oncology with physical examination every 4-6 months and annual mammography and ultrasound as per the consensus of the hospitals breast unit A validated Spanish-language quality of life questionnaire following breast surgery BREAST-Q will be administered by Gynecology at 12 months post-surgery along with evaluation of late postoperative complications
Suspicion of axillary involvement will be ruled out using ultrasound or magnetic resonance imaging as well as distant metastasis with standard staging studies bone scintigraphycomputed tomography of the thorax abdomen and pelvis
Lymphatic mapping will be performed according to each hospitals protocol similar to lymphatic mapping in primary breast cancer The radiotracerdye will be injected according to each centers standard practice peritumoral intratumoral intradermal or periareolar in the quadrant of the tumor the day before or on the day of surgery by Nuclear MedicineRadiology Lymphoscintigraphy will be performed and the detected sentinel lymph nodes SLNs will be marked on the skin with inkmarker In cases where the SLN is not visualized a second dose of radiotracer may be administered
If there is no drainage from the SLN and no prior lymphadenectomy LA additional axillary surgery will not be performed If there is no drainage from the SLN and no prior LA consideration will be given to performing lymphadenectomy according to each centers protocol
During surgery SLNs will be identified using a gamma probe andor dye with assistance from the nuclear medicine service Between one and three SLNs will be removed whether drainage is in the ipsilateral axilla internal mammary or contralateral axilla They will be sent to Pathology for intraoperative or deferred examination by One-Step Nucleic Acid Amplification OSNA or conventional technique
If infiltration is found in any of the axillary SLNs isolated tumor cells micrometastasis or macrometastasis axillary surgery will be completed with a lymphadenectomy including levels I and II of Berg If infiltration is found in internal mammary SLNs and not in axillary SLNs irradiation of the internal mammary chain will be performed recommended dose of 50 Gy without completing the LA If contralateral axillary SLNs are affected further treatment will be decided by consensus in the subsequent treatment committee
A wound care visit with a specialized breast unit nurse will be scheduled for the week after surgery to assess postoperative complications and an outpatient consultation with Gynecology will be scheduled for 3 weeks after surgery for further evaluation
Adjuvant treatment will be administered according to consensus in the hospitals multidisciplinary committee following standard practice
Follow-up will be conducted in outpatient consultations with GynecologyMedical OncologyRadiation Oncology with physical examination every 4-6 months and annual mammography and ultrasound as per the consensus of the hospitals breast unit A validated Spanish-language quality of life questionnaire following breast surgery BREAST-Q will be administered by Gynecology at 12 months post-surgery along with evaluation of late postoperative complications
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None