Preliminary study to evaluate the effectiveness of direct injection of Indian ink and blue methylene in the involved and suspected lymph nodes before and after neoadjuvant chemotherapy in patients with breast cancer and the practical use of this method in detecting theses lymph nodes during surgery.
Preliminary study to evaluate the effectiveness of direct injection of Indian ink and blue methylene in the involved and suspected lymph nodes before and after neoadjuvant chemotherapy in patients with breast cancer and the practical use of this method in detecting theses lymph nodes during surgery.
Design
This preliminary experimental study will be performed at the Cancer Institute of Imam Khomeini Hospital during the year 1401. Breast cancer patients who are candidates for neoadjuvant chemotherapy will enter the study . The sampling method is convenience sampling.
Settings and conduct
Patients are divided into two groups according to the time of neoadjivant chemotherapy. 0/2 cc of Indian ink will be injected in involved lymph nodes under the ultrasound guide .in the next stage, the patient undergoes neo-adjuvant chemotherapy and then , the axillary ultrasound is performed and the procedure will be continued according to the following algorithm. In patients who have received neo-adjuvant before, whether their axillaylymph nodes are involved or not , the ultrasound will be repeated and the process will continue according to the attached algorithm.The details of the lymph nodes after extraction will be written on the relevant container and will be examined by an experienced pathologist.
Participants/Inclusion and exclusion criteria
Breast cancer patients who have finished neoadjuvant chemotherapy and had involved N1-N2 lymph nodes confirmed by pathology or ultrasonography
Intervention groups
Breast cancer patients with positive lymph node before chemotherapy admitted for surgery after chemotherapy.
Main outcome variables
Successful injection of Indian ink
Successful injection of methylen blue
Successfully finding a stained LNs with Indian ink
Successfully finding lymph nodes stained with methylen blue
Involvement of positive lymph nodes after chemotherapy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180720040533N3
Registration date:2022-12-06, 1401/09/15
Registration timing:retrospective
Last update:2022-12-06, 1401/09/15
Update count:0
Registration date
2022-12-06, 1401/09/15
Registrant information
Name
Farzad Vaghef Davari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2213 5448
Email address
fvdavari@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-21, 1401/02/01
Expected recruitment end date
2022-06-21, 1401/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Preliminary study to evaluate the effectiveness of direct injection of Indian ink and blue methylene in the involved and suspected lymph nodes before and after neoadjuvant chemotherapy in patients with breast cancer and the practical use of this method in detecting theses lymph nodes during surgery.
Public title
The effect of Indian ink on the identification of involved lymph nodes in breast cancer
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Breast cancer patients that are candidates for neoadjuvant chemotherapy
Underwenting previous chemotherapy for any reason or candidate for current chemotherapy due to lymph node Involvement
Involvement of lymph nodes confirmed by pathology.
Involvement of lymph nodes ( N1 or N2a)
Exclusion criteria:
Extensive lymph node ( N2b or N30) or skin involvement
Failure to follow the treatment by the patient after the intervention
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Ethics Committee , Central Building of University, Ghods St. , Keshavarz Bld.
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2022-02-16, 1400/11/27
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1400.1370
Health conditions studied
1
Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Finding the involved lymph nodes after neoadjuvant chemotherapy
Timepoint
Indian ink injection the day before surgery and the morning of surgery in one group and also before the beginning of of neoadjuvant chemotherapy in the other group
Method of measurement
details of the lymph nodes will be written on the relevant container after the excision and will be examined by an experienced pathologist, and finally the desired variables will be entered directly in the Data Sheet of SPSS program.
Secondary outcomes
1
Description
Success in injecting Indian ink, success in injecting methylene blue , succeeding in finding lymph nodes stained with Indian ink, succeeding in finding lymph node stained with methylene blue, involvement of affected lymph node after chemotherapy, involvement of suspected lymph node after chemotherapy
Timepoint
After the intervention in the group that has received chemotherapy and after the completion of chemotherapy in the group that will be received chemotherapy
Method of measurement
details of the lymph nodes will be written on the relevant container after the excision and will be examined by an experienced pathologist, and finally the desired variables will be entered directly in the Data Sheet of SPSS program.
Intervention groups
1
Description
Intervention group: breast cancer patients who are candidates for neoadjuvant chemotherapy. If the lymph nodes are involved , the affected lymph nodes will be injected with 0.2 cc of Indian ink under an ultrasound guide (injection is done with an insulin syringe and then 0.1 cc of distilled water is injected to clean the syringe)
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Farzad Vaghef Davari
Street address
Cancer Institute , Imam Khomeini Hospital,Keshavarz Bld.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6119 2998
Email
imamhospital@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzad Vaghef Davari
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Bld.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzad Vaghef Davari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cancer Institute, Imam Khomeini Hospital , Keshavarz Boulevard,
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
00982161190
Email
fvdavari@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzad Vaghef Davari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cancer Institute , Imam Khomeini Hospital , Keshavarz Bld.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
00982161190
Email
fvdavari@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzad Vaghef Davari
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Cancer Institute , Imam Khomeini Hospital , Keshavarz Bld.
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
00982161190
Email
fvdavari@sina.tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no reason
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available