<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/NCT04437602</url>
  </required_header>
  <id_info>
    <org_study_id>2019-02661</org_study_id>
    <nct_id>NCT04437602</nct_id>
  </id_info>
  <brief_title>Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions</brief_title>
  <acronym>PROCEM</acronym>
  <official_title>Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Halland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Halland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients diagnosed with breast cancer after routine assessment with digital mammography and&#xD;
      ultrasound and scheduled for primary surgery are included in the trial. The patients are&#xD;
      randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further&#xD;
      imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a)&#xD;
      mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial&#xD;
      mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral&#xD;
      surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy&#xD;
      instead of primary surgery due to more advanced disease. Rate of reoperation and rate of&#xD;
      avoidable mastectomies are secondary endpoints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Prospective Randomized Trial</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients with change of primary treatment due to findings at additional CEM</measure>
    <time_frame>Within two months after diagnosis of breast cancer</time_frame>
    <description>Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of reoperations</measure>
    <time_frame>Within three months after diagnosis of breast cancer</time_frame>
    <description>Number of reoperations due to inadequate margins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of avoidable mastectomies</measure>
    <time_frame>Within three months after diagnosis of breast cancer</time_frame>
    <description>Patients operated with mastectomy where histopathology shows extent less than 3 cm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">440</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>CEM</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No CEM</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in No intervention arm will go through no additional preoperative imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Contrast Enhanced Mammography (CEM)</intervention_name>
    <description>Additional CEM in preoperative staging</description>
    <arm_group_label>CEM</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planned primary surgery for suspicious or verified breast malignancy Age of 18 years&#xD;
             and above Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned neoadjuvant therapy On-going pregnancy Iodinated contrast agent allergy Renal&#xD;
             failure (abnormal S-creatinine) Untreated thyreotoxicosis Severe heart failure&#xD;
             Myastenia gravis Breast implant Local recurrence as index lesion Inability to&#xD;
             understand and comprehend oral and written information of the study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Breast cancer is very uncommon among men.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristina Ahsberg, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Region Halland</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kristina Ahsberg, PhD</last_name>
    <phone>+46 705 504120</phone>
    <email>kristina.ahsberg@med.lu.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Halland Hospital Halmstad</name>
      <address>
        <city>Halmstad</city>
        <zip>301 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Kristina Ahsberg, PhD</last_name>
      <phone>+46 705 504120</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Helsingborg Hospital</name>
      <address>
        <city>Helsingborg</city>
        <zip>252 23</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pia Lindblom, PhD</last_name>
      <email>pia.lindblom@skane.se</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Central Hospital Kristianstad</name>
      <address>
        <city>Kristianstad</city>
        <zip>291 33</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tor Svensjö, PhD</last_name>
      <email>tor.svensjo@skane.se</email>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Ahsberg K, Gardfjell A, Nimeus E, Ryden L, Zackrisson S. The PROCEM study protocol: Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study. BMC Cancer. 2021 Oct 18;21(1):1115. doi: 10.1186/s12885-021-08832-2.</citation>
    <PMID>34663236</PMID>
  </reference>
  <results_reference>
    <citation>Ahsberg K, Gardfjell A, Nimeus E, Rasmussen R, Behmer C, Zackrisson S, Ryden L. Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study. World J Surg Oncol. 2020 May 21;18(1):100. doi: 10.1186/s12957-020-01865-0.</citation>
    <PMID>32438917</PMID>
  </results_reference>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 18, 2020</study_first_posted>
  <last_update_submitted>April 6, 2023</last_update_submitted>
  <last_update_submitted_qc>April 6, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contrast Enhanced Mammography</keyword>
  <keyword>Preoperative staging</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan</ipd_description>
  </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/NCT04437602
org study id: 2019-02661
nct id: NCT04437602
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients diagnosed with breast cancer after routine assessment with digital mammography and
      ultrasound and scheduled for primary surgery are included in the trial. The patients are
      randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further
      imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a)
      mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial
      mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral
      surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy
      instead of primary surgery due to more advanced disease. Rate of reoperation and rate of
      avoidable mastectomies are secondary endpoints.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective Randomized Trial
primary purpose: Diagnostic
masking: None (Open Label)
measure: Rate of patients with change of primary treatment due to findings at additional CEM
time frame: Within two months after diagnosis of breast cancer
description: Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease
measure: Rate of reoperations
time frame: Within three months after diagnosis of breast cancer
description: Number of reoperations due to inadequate margins
measure: Rate of avoidable mastectomies
time frame: Within three months after diagnosis of breast cancer
description: Patients operated with mastectomy where histopathology shows extent less than 3 cm
arm group label: CEM
arm group type: Experimental
description: Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography
arm group label: No CEM
arm group type: No Intervention
description: Patients in No intervention arm will go through no additional preoperative imaging
intervention type: Diagnostic Test
intervention name: Contrast Enhanced Mammography (CEM)
description: Additional CEM in preoperative staging
arm group label: CEM
criteria: 
gender: Female
gender based: Yes
gender description: Breast cancer is very uncommon among men.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kristina Ahsberg, PhD
role: Principal Investigator
affiliation: Region Halland
last name: Kristina Ahsberg, PhD
phone: +46 705 504120
email: kristina.ahsberg@med.lu.se
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Sweden
citation: Ahsberg K, Gardfjell A, Nimeus E, Ryden L, Zackrisson S. The PROCEM study protocol: Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study. BMC Cancer. 2021 Oct 18;21(1):1115. doi: 10.1186/s12885-021-08832-2.
PMID: 34663236
citation: Ahsberg K, Gardfjell A, Nimeus E, Rasmussen R, Behmer C, Zackrisson S, Ryden L. Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study. World J Surg Oncol. 2020 May 21;18(1):100. doi: 10.1186/s12957-020-01865-0.
PMID: 32438917
responsible party type: Sponsor
sharing ipd: No
ipd description: No plan