ICG fluorescence imaging in partial or breast conservation surgery

A pilot study to evaluate ICG fluorescence imaging to predict flap necrosis in patients undergoing breast surgery - NIL

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/11/059667

Enrollment

Registered

2023-11-08

Start date

Unknown

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site Health Condition 2: O- Medical and Surgical

Interventions

Intervention1: ICG Fluorescence angiography: The ICG Fluorescence angiography done intra-operatively will detect perfusion of the flap which will be recorded on the computer software. This will be cor

Eligibility

Inclusion criteria

Inclusion criteria: Skin sparing, subcutaneous and nipple sparing mastectomy undergoing immediate reconstruction Breast conservation surgery with oncoplastic procedures which involves rotation /transposition /advancement etc Patient voluntarily willing to give informed consent for the study.

Exclusion criteria

Exclusion criteria: Previous irradiation of tumour site Allergic condition to the ICG fluorescence dye Pregnant and lactating patients

Design outcomes

Primary

Measure	Time frame
1. To assess the use of ICG fluoroscopic angiography (FA) to record perfused patterns of flaps intraoperatively. 2. To record and evaluate 30 days post operative morbidity with clavien dindo or CDC classification. 3. To evaluate correlation with long term outcome such as fat necrosis.Timepoint: The patient will be assessed in the outpatient’s department on post-operative day POD2 +/- 1 day (before discharge from the hospital) and POD 14 +/- 2 days (at the time of suture removal) for presence of any flap necrosis and follow up for one month post trial	—

Measure

Time frame

1. To assess the use of ICG fluoroscopic angiography (FA) to record perfused patterns of flaps intraoperatively. 2. To record and evaluate 30 days post operative morbidity with clavien dindo or CDC classification. 3. To evaluate correlation with long term outcome such as fat necrosis.Timepoint: The patient will be assessed in the outpatient’s department on post-operative day POD2 +/- 1 day (before discharge from the hospital) and POD 14 +/- 2 days (at the time of suture removal) for presence of any flap necrosis and follow up for one month post trial

—

Secondary

Measure	Time frame
NilTimepoint: Nil	—

Countries

India

Contacts

Public ContactDrShalaka P Joshi

Tata Memorial Centre

drjoshishalaka@gmail.com02224177198

Outcome results

None listed

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