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JOURNAL ONKOLOGIE – STUDIE
Ultra3Detect

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

Rekrutierend

NCT-Nummer:
NCT04468113

Studienbeginn:
Mai 2020

Letztes Update:
13.07.2020

Wirkstoff:
-

Indikation (Clinical Trials):
Breast Neoplasms

Geschlecht:
Frauen

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kliniken Essen-Mitte

Collaborator:
-

Studienleiter

Sherko Kuemmel, MD, PhD
Principal Investigator
Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany
Mattea Reinisch, MD
Study Chair
Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany
Jörg Heil, MD, PhD
Study Chair
Department of Gynecology, Breast Center, Heidelberg University, Germany

Kontakt

Breast Cancer Trials group (several people), MD or PhD
Kontakt:
Phone: +49201174
Phone (ext.): 33001
E-Mail: breastcancer-trials@kem-med.com
» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Interdisciplinary Breast Unit, Kliniken Essen-Mitte
45136 Essen
(Nordrhein-Westfalen)
GermanyRekrutierend» Google-Maps
Ansprechpartner:
Sherko Kuemmel, MD, PhD
Phone: 020117433001
E-Mail: S.Kuemmel@kem-med.com

Mattea Reinisch, MD
Phone: +4920117433001
E-Mail: M.Reinisch@kem-med.com
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

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.
 

Ein-/Ausschlusskriterien

Inclusion Criteria:

- female patient aged ≥ 18 years

- written informed consent

- patient's consent to NST

- suspicious unilateral or bilateral intramammary foci that can be safely identified by ultrasound

- no evidence of distant metastasis (complete staging does not have to be present at inclusion)

- indication for breast conserving therapy

- no prior clip placement in the confirmed intramammary carcinoma

- patient is able to undergo NST treatment (even if the indication based on tumor biology is not yet available)

- high compliance and high number of planned relevant surgical interventions in participating study center

- patient can understand the scope of this prospective registry study

Exclusion Criteria:

- allergy to titanium and/or nickel

- pregnancy

- ipsilateral relapse (when NST: no exclusion criterion)

- prior extensive breast surgery (starting from quadrant resection)

- inflammatory breast cancer

- extramammary breast cancer

- multicentric or multifocal breast cancer

- patient is not operable

- patient is already undergoing adjuvant/neoadjuvant therapy

- inability to understand the purpose of the clinical trial or to comply with study procedures

Studien-Rationale

Primary outcome:

1. Sonographic detection rate of clip at the time of surgery after completion of NST (Time Frame - At the time of surgery):
Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment



Secondary outcome:

1. Number of ultrasound-guided clip placements per patient (Time Frame - Immediately after placement of clip):
a) Number of lesions marked with a clip per patient and b) Number of clips per lesion

2. Rate of successful clip placements in the tumor center (Time Frame - Immediately after placement of clip):
Not successful: clip placement technically not possible or clip was placed outside the tumor (indication of the distance from the tumor center in mm)

3. Visibility of the device (Tumark® Vision) cannula (Time Frame - During placement of clip):
Visibility (very good, good, sufficient or bad) of the cannula during US-guided clip placement

4. Complications associated with the application of the clip (Time Frame - Up to 6 months after placement of clip):
e.g. hematoma, infection, dislocation, pain (in patients with or without NST)

5. Sonographic detection rate of clips in patients receiving NST (Time Frame - Immediately after placement of clip as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively):
Detection rate at different time points in all patients receiving NST

6. Sonographic detection rate of clips in TNBC and HER2+ patients receiving NST (Time Frame - Immediately after clip placement as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively):
Detection rate at different time points in TNBC or HER2+ breast cancer receiving NST

7. Sonographic detection rate of clips in all patients receiving NST and with pCR (Time Frame - Immediately after clip placement as well as after 4-8, 9-12,13-26 weeks of NST treatment and preoperatively):
Definition of pCR according to residual cancer burden (RCB) score

8. Sonographic detection rate of clips in patients not receiving NST (Time Frame - Immediately after clip placement and preoperatively):
Subgroup of study population not receiving NST

9. Intraoperative detection rate of the clip in specimen radiographs (Time Frame - At the time of surgery):
Detection of clip in surgical specimen from the breast subjected to radiography

10. Intraoperative detection rate of the clip on specimen utrasound images (Time Frame - At the time of surgery):
Detection of clip in surgical specimen from the breast subjected to ultrasonography

11. Proportion of patients requiring preoperative, mammography-guided wire marking (Time Frame - Preoperatively):
If ultrasound-guided wire marking is not feasible, mammography-guided wire marking is performed

12. Proportion of patients with mammographic verification after sonographic wire-marking (Time Frame - Preoperatively):
If ultrasound-guided wire marking is inconclusive

13. Proportion of patients with artifacts caused by clips (Time Frame - Up to 6 months after placement of clip):
On ultrasound and/or mammography images

14. Number of patients with complete pathological remission (Time Frame - Up to 10 weeks after surgery):
ypT0/is, ypN0 status after histological evaluation (according to Residual Cancer Burden [RCB] score) of Symmans (2007)

Geprüfte Regime

  • Tumark® Vision clip:
    Suspicious intramammary lesion is marked with clip

Quelle: ClinicalTrials.gov


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