The effect of Indian ink on the identification of involved lymph nodes in breast cancer

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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180720040533N3

Enrollment

Registered

2022-12-06

Start date

2022-04-21

Completion date

Unknown

Last updated

2023-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer. Malignant neoplasm of breast

Interventions

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

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Extensive lymph node ( N2b or N30) or skin involvement Failure to follow the treatment by the patient after the intervention

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarzad Vaghef Davari

Tehran University of Medical Sciences

fvdavari@sina.tums.ac.ir00982161190

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026