Primary Breast CancerNCT05445050
mULM to Support Breast Cancer Diagnosis and Therapy
A study testing Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS) in people with Primary Breast Cancer, run by RWTH Aachen University at 1 site in Germany.
Trial summary
The goal of this project is to adapt the super-resolution ultrasound imaging technology motion-model Ultrasound Localization Microscopy (mULM) to clinical application. In this exploratory patient study a scan protocol will be established to subsequently investigate whether mULM allows the assessment of the tumor… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Breast Cancer
- What is being tested?
- Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteGermany
- Study dates
- 26 Apr 2021to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- written informed consent
- age ≥ 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes (study parts A and B)
- highly suspected primary breast cancer (study part C)
- treatment with neoadjuvant chemotherapy (study part B)
- persons who are legally competent and mentally able to follow the instructions of the study team
Who cannot join
- younger than 18 years
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- signs of cardiovascular instability
- acute endocarditis
- artificial heart valves
Show all 17Show fewer
- acute systemic inflammation and/or sepsis
- overactive coagulation status and/or recent thromboembolic events
- end stage of liver and kidney diseases
- severe pulmonary hypertension (pulmonary arterial pressure > 90 mmHg)
- uncontrolled systemic hypertension
- acute respiratory distress syndrome
- pregnancy
- commitment of the patient to any resident institution by order of any court or authority
- expectation of missing compliance
- alcohol or drug abuse
- patients who are in a relationship of dependence or in a working relationship to the sponsor, the investigator or his representative
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Gynecology and Obstetrics Universitätsklinikum Aachen, AöR
Aachen, North Rhine-Westphalia, 52074
Elmar Stickeler, +492418088400, estickeler@ukaachen.de
About this study
Official title: Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients
The goal of this project is to adapt the super-resolution ultrasound imaging technology motion-model Ultrasound Localization Microscopy (mULM) to clinical application. In this exploratory patient study a scan protocol will be established to subsequently investigate whether mULM allows the assessment of the tumor response to neoadjuvant chemotherapy in participants with a primary breast cancer diagnosis as well as for the differentiation of benign and malignant breast tumors in participants with lesions of unknown dignity.
Read the detailed description
This study on the clinical translation of the super-resolution ultrasound imaging technique motion-model ultrasound localization microscopy (mULM) is composed of three parts. First, an ultrasound scan protocol will be developed by providing patients with primary breast carcinoma with an ultrasound scan to assess the size, location, and structure of the tumor. Images in the form of B-mode ultrasound, elastography, and contrast ultrasound will be obtained, and mini-movies of the CEUS examinations will be evaluated in a post-processing step. There, individual microbubbles of the ultrasound contrast agent will be identified and tracked to reconstruct the microvasculature of the tumor lesions. Participants will each receive 2 different doses of the clinically approved ultrasound contrast agent SonoVue®. The morphological and functional parameters obtained through the post-processing with the mULM algorithm are then analyzed and subsequently validated with histological examinations. Finally, the ultrasound examination protocol will be optimized and the corresponding dosage of the ultrasound contrast agent determined.
The examination protocol established in the first section will subsequently be applied to patients with primary breast carcinoma receiving neoadjuvant chemotherapy. Contrast-enhanced ultrasonography will be performed at three time points during the chemotherapy cycles and will be performed to assess tumor perfusion through application of the mULM-algorithm. The dosage of contrast agent is based on the dosage found in the previous part of the study. The CEUS examination is followed by the infusion of the chemotherapeutic agent. After completion of neoadjuvant chemotherapy, surgical resection of the tumor and microscopic examination of the tissue are performed according to guidelines.
In the final part of the study, patients with suspected breast tumor lesions are examined. They will first receive non-contrast-enhanced diagnostic ultrasound (B-mode and elastography). A contrast-enhanced ultrasound examination is performed on the largest lesion. To further develop the mULM methodology, this is performed as both 2D and 3D acquisition. The dosage of the contrast agent examination is again based on the optimal dosage found in the first study part. This ultrasound procedure is followed by guideline-guided biopsy for histologic clarification of the tumors, assessing dignity, hormone receptor as well as and HER2/neu status, proliferation rate, and vessel density.
- Conditions
- Primary Breast Cancer
- Being tested
- Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)
- Keywords
- breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)Diagnostic test
Part A: performing CEUS with the contrast agent SonoVue® at two different doses and two different injection speeds in participants with primary breast cancer
Part B: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants undergoing neoadjuvant chemotherapy
Part C: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants with lesions of unknown dignity
| Study group | Role | What they receive |
|---|---|---|
| clinical application of mULM to support breast cancer diagnosis and therapy | Other | The study arm includes three parts A, B and C. In part A, the scan protocol, including the injection of the clinically approved contrast agent SonoVue® and the data acquisition time range, is optimized based on the mULM measurements of participants with primary breast cancer.
The following part B consists of 2D-mULM measurements applied to triple-negative breast cancer patients throughout their neoadjuvant chemotherapy cycles with the aim to evaluate to which degree 2D-mULM allows for an assessment of the tumor response during therapy.
In the last part C, participants with neoplasms of uncertain dignity will be investigated by 2D- and 3D-mULM measurements and the accuracy of differentiation between the lesions assessed. Receives: Diagnostic Test: Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative blood volume
Relative blood volume in % - describes the degree of vascularization - measured with mULM
Measured: Study Part A & C: approximately 1 day before surgical removal of tumor
Blood flow
Blood flow in mm/s - measured with mULM
Measured: Study Part A & C: approximately 1 day before surgical removal of tumor
Change of relative blood volume
Change of relative blood volume in %
Measured: Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)
Change of blood flow
Change of blood flow in mm/s
Measured: Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)
Secondary outcomes (1)
Change of tumor size
Change of tumor size determined based on ultrasound B-mode imaging
Measured: Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start26 Apr 2021
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elmar Stickeler, RWTH Aachen University
- Investigators
- Elmar Stickeler, Prof Dr. med, Principal investigator, RWTH Aachen University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445050
- Sponsor's protocol ID
- 351-19
- Other IDs
- DRKS00023954
- Status last verified
- Nov 2023
- First submitted
- 27 May 2022
- Last updated
- 18 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study results will be published in at least one scientific article.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Motion-Model Ultrasound Localization Microscopy to Support Breast Cancer Diagnosis and Therapy Monitoring in Patients
- ClinicalTrials.gov ID
- NCT05445050
- Acronym / sponsor ID
- 351-19
- Conditions
- Primary Breast Cancer
- Keywords
- breast cancer, neoadjuvant chemotherapy, ultrasound, microbubbles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Oct 2024 (estimated)
- First posted
- 6 Jul 2022 (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.
The goal of this project is to adapt the super-resolution ultrasound imaging technology motion-model Ultrasound Localization Microscopy (mULM) to clinical application. In this exploratory patient study a scan protocol will be established to subsequently investigate whether mULM allows the assessment of the tumor response to neoadjuvant chemotherapy in participants with a primary breast cancer diagnosis as well as for the differentiation of benign and malignant breast tumors in participants with lesions of unknown dignity.
Detailed description
This study on the clinical translation of the super-resolution ultrasound imaging technique motion-model ultrasound localization microscopy (mULM) is composed of three parts. First, an ultrasound scan protocol will be developed by providing patients with primary breast carcinoma with an ultrasound scan to assess the size, location, and structure of the tumor. Images in the form of B-mode ultrasound, elastography, and contrast ultrasound will be obtained, and mini-movies of the CEUS examinations will be evaluated in a post-processing step. There, individual microbubbles of the ultrasound contrast agent will be identified and tracked to reconstruct the microvasculature of the tumor lesions. Participants will each receive 2 different doses of the clinically approved ultrasound contrast agent SonoVue®. The morphological and functional parameters obtained through the post-processing with the mULM algorithm are then analyzed and subsequently validated with histological examinations. Finally, the ultrasound examination protocol will be optimized and the corresponding dosage of the ultrasound contrast agent determined.
The examination protocol established in the first section will subsequently be applied to patients with primary breast carcinoma receiving neoadjuvant chemotherapy. Contrast-enhanced ultrasonography will be performed at three time points during the chemotherapy cycles and will be performed to assess tumor perfusion through application of the mULM-algorithm. The dosage of contrast agent is based on the dosage found in the previous part of the study. The CEUS examination is followed by the infusion of the chemotherapeutic agent. After completion of neoadjuvant chemotherapy, surgical resection of the tumor and microscopic examination of the tissue are performed according to guidelines.
In the final part of the study, patients with suspected breast tumor lesions are examined. They will first receive non-contrast-enhanced diagnostic ultrasound (B-mode and elastography). A contrast-enhanced ultrasound examination is performed on the largest lesion. To further develop the mULM methodology, this is performed as both 2D and 3D acquisition. The dosage of the contrast agent examination is again based on the optimal dosage found in the first study part. This ultrasound procedure is followed by guideline-guided biopsy for histologic clarification of the tumors, assessing dignity, hormone receptor as well as and HER2/neu status, proliferation rate, and vessel density.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| clinical application of mULM to support breast cancer diagnosis and therapy | Other | Diagnostic Test: Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)The study arm includes three parts A, B and C. In part A, the scan protocol, including the injection of the clinically approved contrast agent SonoVue® and the data acquisition time range, is optimized based on the mULM measurements of participants with primary breast cancer. The following part B consists of 2D-mULM measurements applied to triple-negative breast cancer patients throughout their neoadjuvant chemotherapy cycles with the aim to evaluate to which degree 2D-mULM allows for an assessment of the tumor response during therapy. In the last part C, participants with neoplasms of uncertain dignity will be investigated by 2D- and 3D-mULM measurements and the accuracy of differentiation between the lesions assessed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- written informed consent
- age ≥ 18 yrs
- histologically confirmed primary breast cancer including all intrinsic subtypes (study parts A and B)
- highly suspected primary breast cancer (study part C)
- treatment with neoadjuvant chemotherapy (study part B)
Key exclusion criteria (17 listed)
- younger than 18 years
- hypersensitivity / allergy to sulfur hexafluoride, Macrogol 4000, distearoylphosphatidylcholine, dipalmitoylphosphatidylglycerol-sodium, palmitic acid
- right-left shunt,
- signs of cardiovascular instability
- acute endocarditis
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 |
|---|---|---|
| Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS)Part A: performing CEUS with the contrast agent SonoVue® at two different doses and two different injection speeds in participants with primary breast cancer Part B: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants undergoing neoadjuvant chemotherapy Part C: performing CEUS with the contrast agent SonoVue® using the established protocol from part A in participants with lesions of unknown dignity | Diagnostic test | clinical application of mULM to support breast cancer diagnosis and therapy |
Primary outcome
Relative blood volume
Time frame: Study Part A & C: approximately 1 day before surgical removal of tumor
Relative blood volume in % - describes the degree of vascularization - measured with mULM
Blood flow
Time frame: Study Part A & C: approximately 1 day before surgical removal of tumor
Blood flow in mm/s - measured with mULM
Change of relative blood volume
Time frame: Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)
Change of relative blood volume in %
Change of blood flow
Time frame: Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)
Change of blood flow in mm/s
1 secondary outcome
Change of tumor size
Time frame: Study Part B: at the beginning of (approximately 1 hour before) first, second and fourth cycle of neoadjuvant chemotherapeutic treatment (each cycle is 14 days)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No. The study results will be published in at least one scientific article.
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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.
Elmar Stickeler, Prof Dr. med principal investigator
RWTH Aachen University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application and measurement of tumor vascularization using diagnostic contrast enhanced ultrasound (CEUS) in people with Primary Breast Cancer, run by RWTH Aachen University at 1 site in Germany.
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 6 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elmar Stickeler, Prof Dr. med (+492418088400, estickeler@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative blood volume (time frame: Study Part A & C: approximately 1 day before surgical removal of tumor). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2023.