<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04468113</url>
  </required_header>
  <id_info>
    <org_study_id>V2_16-04-2020</org_study_id>
    <nct_id>NCT04468113</nct_id>
  </id_info>
  <brief_title>Clip Marker Placement in Primary Lesions of Breast Cancer Patients Receiving Neoadjuvant Therapy</brief_title>
  <acronym>Ultra3Detect</acronym>
  <official_title>Prospective, Multicenter Registry Study Evaluating the Feasibility of Ultrasound-guided Clipping of Suspicious Intramammary Lesions in Primary Breast Cancer Patients Receiving Neoadjuvant Therapy (Ultra3Detect)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kliniken Essen-Mitte</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kliniken Essen-Mitte</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Neoadjuvant systemic therapy (NST) is increasingly recommended for patients with early breast&#xD;
      cancer, and the rate of patients with pathological complete remission (pCR) is increasing due&#xD;
      to the use of modern chemotherapy regimens and targeted therapies, especially in patients&#xD;
      with human epidermal growth factor receptor 2 positive (HER2+) breast cancer and triple&#xD;
      negative breast cancer (TNBC). It is therefore important to mark a lesion (with e.g. clip)&#xD;
      before the start of NST in order to safely identify and localize a clip and (former) tumor&#xD;
      bed after completion of NST. Reliable sonographic detection of the clip would be preferred to&#xD;
      mammography-guided detection and marking. In addition to avoiding radiation exposure by&#xD;
      mammography and reducing time, personnel and financial expenditure, ultrasound-guided wire&#xD;
      marking of the clip is less painful for the patient than stereotactic wire marking.&#xD;
&#xD;
      The present prospective registry study aims to evaluate how often the intramammary Tumark®&#xD;
      Vision clip can be detected by ultrasound after completion of NST in patients with TNBC and&#xD;
      HER2+ breast cancer and thus, in the case of pCR, how often the elaborate clipping with&#xD;
      mammographic (stereotactic) guidance can be avoided.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Breast cancer patients whose carcinomas have an aggressive tumor biology which implies the&#xD;
      need for chemotherapy are increasingly being treated with NST. As a standard procedure, clip&#xD;
      placement of the suspicious lesion is performed after ultrasound-guided core biopsy or&#xD;
      mammography-guided vacuum biopsy. Clipping is necessary to enable the clear identification of&#xD;
      the sonographically suspicious area of the breast and safe surgical removal of the remaining&#xD;
      tumor tissue (if any) during a later surgery, even following a good response under NST. The&#xD;
      placement of a marker (clip) is particularly important for the precise localization of the&#xD;
      original tumor bed in patients with pCR.&#xD;
&#xD;
      There are a number of commercially available markers (clips) which are indicated for&#xD;
      intramammary marking of a lesion and which differ in terms of shape and material.&#xD;
      Difficulties may arise in placing the clip in the tumor or the tumor center. In addition, the&#xD;
      clip can dislocate from the initial location and/or the clip might not be visualized during&#xD;
      response monitoring. Evaluations of the ultrasound-visible clip made of nitinol investigated&#xD;
      in this study showed very good results regarding marker dislocation and visibility within 7&#xD;
      days after inital placement.The clip, which immediately unfolds into a 3-dimensional&#xD;
      spherical structure after insertion into the tissue, could be detected by both sonography and&#xD;
      mammography in all 50 cases after the intervention; however, long-term data data at follow-up&#xD;
      controls during and after NST are not available so far.&#xD;
&#xD;
      According to current German guidelines, imaging-assisted wire marking is recommended without&#xD;
      restriction before breast conserving surgery for non-palpable lesions. The clip is considered&#xD;
      the target lesion for wire marking, which can be done under sonographic or stereotactic&#xD;
      control. If the clip is reliably visible on ultrasound (even in patients with pCR), the&#xD;
      stereotactic control of wire marking can be omitted. Therefore, the ability to visualize a&#xD;
      clip in breast ultrasonography is of great importance.&#xD;
&#xD;
      The present multicenter study aims to evaluate the sonographic detection rate of the&#xD;
      intramammary Tumark® Vision clips after NST in clinical routine and the proportion of cases&#xD;
      in which the clip cannot be detected, and thus the rate of mammography-guided wire markings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 14, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sonographic detection rate of clip at the time of surgery after completion of NST</measure>
    <time_frame>At the time of surgery</time_frame>
    <description>Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of ultrasound-guided clip placements per patient</measure>
    <time_frame>Immediately after placement of clip</time_frame>
    <description>a) Number of lesions marked with a clip per patient and b) Number of clips per lesion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of successful clip placements in the tumor center</measure>
    <time_frame>Immediately after placement of clip</time_frame>
    <description>Not successful: clip placement technically not possible or clip was placed outside the tumor (indication of the distance from the tumor center in mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Visibility of the device (Tumark® Vision) cannula</measure>
    <time_frame>During placement of clip</time_frame>
    <description>Visibility (very good, good, sufficient or bad) of the cannula during US-guided clip placement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications associated with the application of the clip</measure>
    <time_frame>Up to 6 months after placement of clip</time_frame>
    <description>e.g. hematoma, infection, dislocation, pain (in patients with or without NST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic detection rate of clips in patients receiving NST</measure>
    <time_frame>Immediately after placement of clip as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively</time_frame>
    <description>Detection rate at different time points in all patients receiving NST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic detection rate of clips in TNBC and HER2+ patients receiving NST</measure>
    <time_frame>Immediately after clip placement as well as after 4-8, 9-12, 13-26 weeks of NST treatment and preoperatively</time_frame>
    <description>Detection rate at different time points in TNBC or HER2+ breast cancer receiving NST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic detection rate of clips in all patients receiving NST and with pCR</measure>
    <time_frame>Immediately after clip placement as well as after 4-8, 9-12,13-26 weeks of NST treatment and preoperatively</time_frame>
    <description>Definition of pCR according to residual cancer burden (RCB) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sonographic detection rate of clips in patients not receiving NST</measure>
    <time_frame>Immediately after clip placement and preoperatively</time_frame>
    <description>Subgroup of study population not receiving NST</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative detection rate of the clip in specimen radiographs</measure>
    <time_frame>At the time of surgery</time_frame>
    <description>Detection of clip in surgical specimen from the breast subjected to radiography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative detection rate of the clip on specimen utrasound images</measure>
    <time_frame>At the time of surgery</time_frame>
    <description>Detection of clip in surgical specimen from the breast subjected to ultrasonography</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring preoperative, mammography-guided wire marking</measure>
    <time_frame>Preoperatively</time_frame>
    <description>If ultrasound-guided wire marking is not feasible, mammography-guided wire marking is performed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with mammographic verification after sonographic wire-marking</measure>
    <time_frame>Preoperatively</time_frame>
    <description>If ultrasound-guided wire marking is inconclusive</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with artifacts caused by clips</measure>
    <time_frame>Up to 6 months after placement of clip</time_frame>
    <description>On ultrasound and/or mammography images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with complete pathological remission</measure>
    <time_frame>Up to 10 weeks after surgery</time_frame>
    <description>ypT0/is, ypN0 status after histological evaluation (according to Residual Cancer Burden [RCB] score) of Symmans (2007)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Primary Breast Cancer</condition>
  <arm_group>
    <arm_group_label>US-guided core biopsy and clip placement</arm_group_label>
    <description>Female patients with sonographically suspicious, intramammary foci, scheduled for ultrasound-guided core biopsy and marking of the lesion with the Tumark® Vision Clip</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Tumark® Vision clip</intervention_name>
    <description>Suspicious intramammary lesion is marked with clip</description>
    <arm_group_label>US-guided core biopsy and clip placement</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Formalin fixed tissue from routine histopathology assessment&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients with sonographically suspicious unilateral or bilateral intramammary foci,&#xD;
        scheduled for sonography-guided core biopsy and marking of the lesion with the Tumark®&#xD;
        Vision Clip.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  female patient aged ≥ 18 years&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
          -  patient's consent to NST&#xD;
&#xD;
          -  suspicious unilateral or bilateral intramammary foci that can be safely identified by&#xD;
             ultrasound&#xD;
&#xD;
          -  no evidence of distant metastasis (complete staging does not have to be present at&#xD;
             inclusion)&#xD;
&#xD;
          -  indication for breast conserving therapy&#xD;
&#xD;
          -  no prior clip placement in the confirmed intramammary carcinoma&#xD;
&#xD;
          -  patient is able to undergo NST treatment (even if the indication based on tumor&#xD;
             biology is not yet available)&#xD;
&#xD;
          -  high compliance and high number of planned relevant surgical interventions in&#xD;
             participating study center&#xD;
&#xD;
          -  patient can understand the scope of this prospective registry study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  allergy to titanium and/or nickel&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  ipsilateral relapse (when NST: no exclusion criterion)&#xD;
&#xD;
          -  prior extensive breast surgery (starting from quadrant resection)&#xD;
&#xD;
          -  inflammatory breast cancer&#xD;
&#xD;
          -  extramammary breast cancer&#xD;
&#xD;
          -  multicentric or multifocal breast cancer&#xD;
&#xD;
          -  patient is not operable&#xD;
&#xD;
          -  patient is already undergoing adjuvant/neoadjuvant therapy&#xD;
&#xD;
          -  inability to understand the purpose of the clinical trial or to comply with study&#xD;
             procedures&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>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.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sherko Kuemmel, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mattea Reinisch, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jörg Heil, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Gynecology, Breast Center, Heidelberg University, Germany</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sherko Kümmel, MD, PhD</last_name>
    <phone>+49 201174</phone>
    <phone_ext>33001</phone_ext>
    <email>S.Kuemmel@kem-med.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Breast Cancer Trials group (several people), MD or PhD</last_name>
    <phone>+49201174</phone>
    <phone_ext>33001</phone_ext>
    <email>breastcancer-trials@kem-med.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Interdisciplinary Breast Unit, Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <zip>45136</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherko Kuemmel, MD, PhD</last_name>
      <phone>020117433001</phone>
      <email>S.Kuemmel@kem-med.com</email>
    </contact>
    <contact_backup>
      <last_name>Mattea Reinisch, MD</last_name>
      <phone>+4920117433001</phone>
      <email>M.Reinisch@kem-med.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Ruland AM, Hagemann F, Reinisch M, Holtschmidt J, Kummel A, Dittmer-Grabowski C, Stoblen F, Rotthaus H, Dreesmann V, Blohmer JU, Kummel S. Using a New Marker Clip System in Breast Cancer: Tumark Vision(R) Clip - Feasibility Testing in Everyday Clinical Practice. Breast Care (Basel). 2018 Apr;13(2):116-120. doi: 10.1159/000486388. Epub 2018 Mar 9.</citation>
    <PMID>29887788</PMID>
  </reference>
  <reference>
    <citation>Hurvitz SA, Martin M, Symmans WF, Jung KH, Huang CS, Thompson AM, Harbeck N, Valero V, Stroyakovskiy D, Wildiers H, Campone M, Boileau JF, Beckmann MW, Afenjar K, Fresco R, Helms HJ, Xu J, Lin YG, Sparano J, Slamon D. Neoadjuvant trastuzumab, pertuzumab, and chemotherapy versus trastuzumab emtansine plus pertuzumab in patients with HER2-positive breast cancer (KRISTINE): a randomised, open-label, multicentre, phase 3 trial. Lancet Oncol. 2018 Jan;19(1):115-126. doi: 10.1016/S1470-2045(17)30716-7. Epub 2017 Nov 23.</citation>
    <PMID>29175149</PMID>
  </reference>
  <reference>
    <citation>von Minckwitz G, Untch M, Blohmer JU, Costa SD, Eidtmann H, Fasching PA, Gerber B, Eiermann W, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Konecny GE, Denkert C, Nekljudova V, Mehta K, Loibl S. Definition and impact of pathologic complete response on prognosis after neoadjuvant chemotherapy in various intrinsic breast cancer subtypes. J Clin Oncol. 2012 May 20;30(15):1796-804. doi: 10.1200/JCO.2011.38.8595. Epub 2012 Apr 16.</citation>
    <PMID>22508812</PMID>
  </reference>
  <reference>
    <citation>Shah AD, Mehta AK, Talati N, Brem R, Margolies LR. Breast tissue markers: Why? What's out there? How do I choose? Clin Imaging. 2018 Nov-Dec;52:123-136. doi: 10.1016/j.clinimag.2018.07.003. Epub 2018 Jul 6.</citation>
    <PMID>30059952</PMID>
  </reference>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>August 17, 2021</last_update_submitted>
  <last_update_submitted_qc>August 17, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>clip</keyword>
  <keyword>ultrasound</keyword>
  <keyword>neoadjuvant therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04468113
org study id: V2_16-04-2020
nct id: NCT04468113
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
observational model: Cohort
time perspective: Prospective
measure: Sonographic detection rate of clip at the time of surgery after completion of NST
time frame: At the time of surgery
description: Intraoperative detection rate of the clip in patients with HER2+ breast cancer or TNBC after at least 12 weeks of NST treatment
measure: Number of ultrasound-guided clip placements per patient
time frame: Immediately after placement of clip
description: a) Number of lesions marked with a clip per patient and b) Number of clips per lesion
measure: Rate of successful clip placements in the tumor center
time frame: Immediately after placement of clip
description: Not successful: clip placement technically not possible or clip was placed outside the tumor (indication of the distance from the tumor center in mm)
measure: Visibility of the device (Tumark® Vision) cannula
time frame: During placement of clip
description: Visibility (very good, good, sufficient or bad) of the cannula during US-guided clip placement
measure: Complications associated with the application of the clip
time frame: Up to 6 months after placement of clip
description: e.g. hematoma, infection, dislocation, pain (in patients with or without NST)
measure: 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
description: Detection rate at different time points in all patients receiving NST
measure: 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
description: Detection rate at different time points in TNBC or HER2+ breast cancer receiving NST
measure: 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
description: Definition of pCR according to residual cancer burden (RCB) score
measure: Sonographic detection rate of clips in patients not receiving NST
time frame: Immediately after clip placement and preoperatively
description: Subgroup of study population not receiving NST
measure: Intraoperative detection rate of the clip in specimen radiographs
time frame: At the time of surgery
description: Detection of clip in surgical specimen from the breast subjected to radiography
measure: Intraoperative detection rate of the clip on specimen utrasound images
time frame: At the time of surgery
description: Detection of clip in surgical specimen from the breast subjected to ultrasonography
measure: Proportion of patients requiring preoperative, mammography-guided wire marking
time frame: Preoperatively
description: If ultrasound-guided wire marking is not feasible, mammography-guided wire marking is performed
measure: Proportion of patients with mammographic verification after sonographic wire-marking
time frame: Preoperatively
description: If ultrasound-guided wire marking is inconclusive
measure: Proportion of patients with artifacts caused by clips
time frame: Up to 6 months after placement of clip
description: On ultrasound and/or mammography images
measure: Number of patients with complete pathological remission
time frame: Up to 10 weeks after surgery
description: ypT0/is, ypN0 status after histological evaluation (according to Residual Cancer Burden [RCB] score) of Symmans (2007)
arm group label: US-guided core biopsy and clip placement
description: Female patients with sonographically suspicious, intramammary foci, scheduled for ultrasound-guided core biopsy and marking of the lesion with the Tumark® Vision Clip
intervention type: Device
intervention name: Tumark® Vision clip
description: Suspicious intramammary lesion is marked with clip
arm group label: US-guided core biopsy and clip placement
Formalin fixed tissue from routine histopathology assessment
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: 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.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sherko Kuemmel, MD, PhD
role: Principal Investigator
affiliation: Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany
last name: Mattea Reinisch, MD
role: Study Chair
affiliation: Interdisciplinary Breast Unit, Kliniken Essen-Mitte, Germany
last name: Jörg Heil, MD, PhD
role: Study Chair
affiliation: Department of Gynecology, Breast Center, Heidelberg University, Germany
last name: Sherko Kümmel, MD, PhD
phone: +49 201174
phone ext: 33001
email: S.Kuemmel@kem-med.com
last name: Breast Cancer Trials group (several people), MD or PhD
phone: +49201174
phone ext: 33001
email: breastcancer-trials@kem-med.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Germany
citation: Ruland AM, Hagemann F, Reinisch M, Holtschmidt J, Kummel A, Dittmer-Grabowski C, Stoblen F, Rotthaus H, Dreesmann V, Blohmer JU, Kummel S. Using a New Marker Clip System in Breast Cancer: Tumark Vision(R) Clip - Feasibility Testing in Everyday Clinical Practice. Breast Care (Basel). 2018 Apr;13(2):116-120. doi: 10.1159/000486388. Epub 2018 Mar 9.
PMID: 29887788
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responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No