Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Female patients with sonographically suspicious, intramammary foci, scheduled for ultrasound-guided core biopsy and marking of the lesion with the Tumark® Vision Clip

Suspicious intramammary lesion is marked with clip

Tumark® Vision clip

Sherko Kuemmel, MD, PhD

Mattea Reinisch, MD

Jörg Heil, MD, PhD

Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast cancer, and the rate of patients with pathological complete remission (pCR) is increasing due to the use of modern chemotherapy regimens and targeted therapies, especially in patients with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip) before the start of NST in order to safely identify and localize a clip and (former) tumor bed after completion of NST. Reliable sonographic detection of the clip would be preferred to mammography-guided detection and marking. In addition to avoiding radiation exposure by mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire marking of the clip is less painful for the patient than stereotactic wire marking.

The present prospective registry study aims to evaluate how often the intramammary Tumark® Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with mammographic (stereotactic) guidance can be avoided.

Breast cancer patients whose carcinomas have an aggressive tumor biology which implies the need for chemotherapy are increasingly being treated with NST. As a standard procedure, clip placement of the suspicious lesion is performed after ultrasound-guided core biopsy or mammography-guided vacuum biopsy. Clipping is necessary to enable the clear identification of the sonographically suspicious area of the breast and safe surgical removal of the remaining tumor tissue (if any) during a later surgery, even following a good response under NST. The placement of a marker (clip) is particularly important for the precise localization of the original tumor bed in patients with pCR.

There are a number of commercially available markers (clips) which are indicated for intramammary marking of a lesion and which differ in terms of shape and material. Difficulties may arise in placing the clip in the tumor or the tumor center. In addition, the clip can dislocate from the initial location and/or the clip might not be visualized during response monitoring. Evaluations of the ultrasound-visible clip made of nitinol investigated in this study showed very good results regarding marker dislocation and visibility within 7 days after inital placement.The clip, which immediately unfolds into a 3-dimensional spherical structure after insertion into the tissue, could be detected by both sonography and mammography in all 50 cases after the intervention; however, long-term data data at follow-up controls during and after NST are not available so far.

According to current German guidelines, imaging-assisted wire marking is recommended without restriction before breast conserving surgery for non-palpable lesions. The clip is considered the target lesion for wire marking, which can be done under sonographic or stereotactic control. If the clip is reliably visible on ultrasound (even in patients with pCR), the stereotactic control of wire marking can be omitted. Therefore, the ability to visualize a clip in breast ultrasonography is of great importance.

The present multicenter study aims to evaluate the sonographic detection rate of the intramammary Tumark® Vision clips after NST in clinical routine and the proportion of cases in which the clip cannot be detected, and thus the rate of mammography-guided wire markings.

Formalin fixed tissue from routine histopathology assessment

Patients with a suspicious intramammary lesion in the breast are identified as female during presentation in the clinic according to their health insurance ID card.

Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy

Prospective, Multicenter Registry Study Evaluating the Feasibility of Ultrasound-guided Clipping of Suspicious Intramammary Lesions in Primary Breast Cancer Patients Receiving Neoadjuvant Therapy (Ultra3Detect)

Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment

a) Number of lesions marked with a clip per patient and b) Number of clips per lesion

Not successful: clip placement technically not possible or clip was placed outside the tumor (indication of the distance from the tumor center in mm)

Visibility (very good, good, sufficient or bad) of the cannula during US-guided clip placement

e.g. hematoma, infection, dislocation, pain (in patients with or without NST)

Detection rate at different time points in all patients receiving NST

Detection rate at different time points in TNBC or HER2+ breast cancer receiving NST

Definition of pCR according to residual cancer burden (RCB) score

Subgroup of study population not receiving NST

Detection of clip in surgical specimen from the breast subjected to radiography

Detection of clip in surgical specimen from the breast subjected to ultrasonography

If ultrasound-guided wire marking is not feasible, mammography-guided wire marking is performed

If ultrasound-guided wire marking is inconclusive

ypT0/is, ypN0 status after histological evaluation (according to Residual Cancer Burden \[RCB\] score) of Symmans (2007)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy	NCT04468113	Primary Breast ...	Tumark® Vision ...	18 Years -	Kliniken Essen-Mitte
Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy	NCT04468113	Primary Breast ...	Tumark® Vision ...	18 Years -	Kliniken Essen-Mitte

Spots Global Cancer Trial Database for tumark® vision clip