Breast CancerPROCEMNCT04437602
Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions
A study testing Contrast Enhanced Mammography (CEM) in people with Breast Cancer, run by Region Halland at 3 sites in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Contrast Enhanced Mammography (CEM)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 441 participants
- Where
- 3 sitesSweden
- Study dates
- 2 Nov 2020to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Planned primary surgery for suspicious or verified breast malignancy Age of 18 years and above Signed informed consent
Who cannot join
- Planned neoadjuvant therapy On-going pregnancy Iodinated contrast agent allergy Renal failure (abnormal S-creatinine) Untreated thyreotoxicosis Severe heart failure Myastenia gravis Breast implant Local recurrence as index lesion Inability to understand and comprehend oral and written information of the study
Trial locations and contacts
3 sites in 1 country.
Sweden3 sites
Halland Hospital Halmstad
Halmstad, 301 85
Helsingborg Hospital
Helsingborg, 252 23
Central Hospital Kristianstad
Kristianstad, 291 33
About this study
Official title: Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial
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.
- Conditions
- Breast Cancer
- Being tested
- Contrast Enhanced Mammography (CEM)
- Keywords
- Contrast Enhanced Mammography, Preoperative staging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Contrast Enhanced Mammography (CEM)Diagnostic test
Additional CEM in preoperative staging
| Study group | Role | What they receive |
|---|---|---|
| CEM | Experimental | Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography Receives: Diagnostic Test: Contrast Enhanced Mammography (CEM) |
| No CEM | No intervention | Patients in No intervention arm will go through no additional preoperative imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of patients with change of primary treatment due to findings at additional CEM
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
Measured: Within two months after diagnosis of breast cancer
Secondary outcomes (2)
Rate of reoperations
Number of reoperations due to inadequate margins
Measured: Within three months after diagnosis of breast cancer
Rate of avoidable mastectomies
Patients operated with mastectomy where histopathology shows extent less than 3 cm
Measured: Within three months after diagnosis of breast cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start2 Nov 2020
- Primary completion30 Apr 2024
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Trial
- Masking
- None (open label)
- Enrolment
- 441 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Halland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Ahsberg, PhD, Principal investigator, Region Halland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437602
- Sponsor's protocol ID
- 2019-02661
- Other IDs
- 2019
- Acronym
- PROCEM
- Status last verified
- May 2024
- First submitted
- 27 May 2020
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan
Publications
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.
PubMed 34663236Ahsberg 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.
PubMed 32438917Gardfjell A, Ryden L, Nimeus E, Zackrisson S, Ahsberg K. Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions (PROCEM): A Randomized Controlled Trial. Radiology. 2026 Nov;321(2):e260857. doi: 10.1148/radiol.260857.
PubMed 42975301
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial
- ClinicalTrials.gov ID
- NCT04437602
- Acronym / sponsor ID
- PROCEM / 2019-02661
- Conditions
- Breast Cancer
- Keywords
- Contrast Enhanced Mammography, Preoperative staging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 441 participants (actual)
- Lead sponsor
- Region HallandUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 18 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective Randomized Trial
| Arm | Type | Receives |
|---|---|---|
| CEM | Experimental | Diagnostic Test: Contrast Enhanced Mammography (CEM)Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography |
| No CEM | No intervention | –Patients in No intervention arm will go through no additional preoperative imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Planned primary surgery for suspicious or verified breast malignancy Age of 18 years and above Signed informed consent
Key exclusion criteria (1 listed)
- Planned neoadjuvant therapy On-going pregnancy Iodinated contrast agent allergy Renal failure (abnormal S-creatinine) Untreated thyreotoxicosis Severe heart failure Myastenia gravis Breast implant Local recurrence as index lesion Inability to understand and comprehend oral and written information of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Contrast Enhanced Mammography (CEM)Additional CEM in preoperative staging | Diagnostic test | CEM |
Primary outcome
Rate of patients with change of primary treatment due to findings at additional CEM
Time frame: Within two months after diagnosis of breast cancer
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
2 secondary outcomes
Rate of reoperations
Time frame: Within three months after diagnosis of breast cancer
Rate of avoidable mastectomies
Time frame: Within three months after diagnosis of breast cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Background: PubMed 34663236Ahsberg 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.
- Results publication: PubMed 32438917Ahsberg 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.
- Derived from this study: PubMed 42975301Gardfjell A, Ryden L, Nimeus E, Zackrisson S, Ahsberg K. Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions (PROCEM): A Randomized Controlled Trial. Radiology. 2026 Nov;321(2):e260857. doi: 10.1148/radiol.260857.
- Individual participant dataSharing planned: No. No plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina Ahsberg, PhD principal investigator
Region Halland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Contrast Enhanced Mammography (CEM) in people with Breast Cancer, run by Region Halland at 3 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04437602, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.