Breast CancerPhase 2NCT06444269
Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
A Phase 2 study testing Radiomics on MRI and microbubble CEUS Contrast Enhanced Ultrasound (CEUS) in people with Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
1. Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor 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?
- Radiomics on MRI and microbubble CEUS Contrast Enhanced Ultrasound (CEUS)
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2024to 1 Jul 2028
- Phase
- Phase 2
- 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
- Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis. It is recommended that these tumors are at least 1 cm for cohort 1 and less than 1 cm for cohort 2, however this is not required.
- Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam
- Age >/= 18 years old and female
- If the tumor is unifocal, greatest tumor dimension is 3cm or less based on imaging.
- Multifocal disease may be included if the aggregate span of disease is 3 cm or less, subject to investigator evaluation and approval.
- The tumor must be visible on CTor MRI scan or preferably marked with clip(s) in tumor if not visible.
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- Patients must have undergone standard of care breast MRI or contrast-enhanced mammography for work up to aid in tumor delineation and to rule out multicentric disease. If areas suspicious of multicentric disease are seen which are beyond the scope of SBRT, they need to have a negative biopsy to proceed with treatment.
- Clinically and radiographically node negative on ultrasound of the axilla or MRI on initial workup prior to microbubble contrast assessment (for cohort 1).
- Estrogen receptor positive or Progesterone receptor positive and Her2neu negative Ability to understand and the willingness to sign a written informed consent. 10. Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control) prior to the start of study and for the duration of radiation therapy as well as the endocrine therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately A female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- Has not undergone a hysterectomy or bilateral oophorectomy; or
- Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months
- For Cohort 1: If patient has had a prior biopsy clip placed in the lymph node deemed the sentinel lymph node at time of microbubble CEUS, it is up to investigator if additional biopsy and clip placement will be obtained.
Who cannot join
- Multi-centric disease
- Prior Radiation to the involved breast
- Aggregate or single tumor Size >3cm
- Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females
- Prior ipsilateral breast cancer
- Patients with active lupus or scleroderma
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- Patients unable to have MRI or contrast-enhanced mammography per physician assessment.
- For Cohort 1: If patient has a positive lymph node at time of microbubble contrast enhanced ultrasound, they will be removed from the study. Only cN0 patients to be treated on this study.
- Healthy Volunteer Inclusion Criteria
- Ability to understand and the willingness to sign a written informed consent.
- Age >/= 18 years old and female
- Without current diagnosis of breast cancer
- Healthy Volunteer Exclusion Criteria
- Contraindication ot MRI
- Volunteers who are pregnant
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UT Southwestern Medical Center-Dallas
Dallas, Texas, 75390
Sarah Neufeld, MS, Sarah.Neufeld@utsouthwestern.edu
About this study
- Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
- Conditions
- Breast Cancer
- Being tested
- Radiomics on MRI, microbubble CEUS Contrast Enhanced Ultrasound (CEUS)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiomics on MRIRadiation
Through extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic "Shell" feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence.
microbubble CEUS Contrast Enhanced Ultrasound (CEUS)Drug
Microbubble Contrast non-FDA approved for route of administration
What is being measured
The primary outcome is the main question the study is designed to answer.
Single fraction pre-operative radiation
To determine efficacy of single fraction 30 Gy pre-operative radiation in early-stage ER+ breast cancer patients and determine pathologic complete response rate at 10-15 months after radiation. Patients that have not had a complete imaging response on MRI, OA, or on needle biopsy at 9 months will move onto a second fraction of PULSAR radiation of 8 Gy at 9-10 months. Surgery will be at 10-12 months for those with complete imaging response and negative needle biopsy. For those with residual disease surgery will be postponed to 12-15 months.
Measured: 4 years
Secondary outcomes (1)
Microbubble contrast
To evaluate the potential of microbubble contrast enhanced ultrasound (CEUS) as a non-operative alternative to sentinel lymph node mapping and biopsy in early-stage ER+ Breast Cancer patients undergoing pre -operative single fraction radiation. Assess concordance of preoperative and pre-radiation microbubble CEUS with SLN mapping and biopsy at time of partial mastectomy.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start11 Oct 2024
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asal Rahimi, University of Texas Southwestern Medical Center
- Investigators
- Asal Rahimi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444269
- Sponsor's protocol ID
- STU-2024-0561
- Status last verified
- Nov 2025
- First submitted
- 30 May 2024
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Medicine in Action: Phase II Trial of Response Adaptive Ablative Pre-operative SPBI (RAPS) and Non-operative Sentinel Lymph Node Biopsy in Patients With Early-stage ER+ Breast Cancer: RAPS Trial
- ClinicalTrials.gov ID
- NCT06444269
- Acronym / sponsor ID
- STU-2024-0561
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 53 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 5 Jun 2024 (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.
- Efficacy of PULSAR preoperative radiation 2. Evaluate potential of microbubble CEUS as an alternative to operative SLNBx 3. Evaluate potential of OA to evaluate treatment response of pre-operative radiation on the tumor
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Invasive epithelial (ductal, medullary, lobular, papillary, mucinous (colloid), or tubular) histologies of the breast 3 cm or less(T1-T2cN0) in women who have not undergone surgery or neoadjuvant endocrine or chemotherapy for current breast cancer diagnosis. It is recommended that these tumors are at least 1 cm for cohort 1 and less than 1 cm for cohort 2, however this is not required.
- Tumor must not involve the overlying skin based on imaging evaluation and/or clinical exam
- Age >/= 18 years old and female
- If the tumor is unifocal, greatest tumor dimension is 3cm or less based on imaging.
- Multifocal disease may be included if the aggregate span of disease is 3 cm or less, subject to investigator evaluation and approval.
Key exclusion criteria (15 listed)
- Multi-centric disease
- Prior Radiation to the involved breast
- Aggregate or single tumor Size >3cm
- Patients who are pregnant or lactating due to the potential exposure to the fetus to radiation therapy and unknown effects of radiation therapy to lactating females
- Prior ipsilateral breast cancer
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 |
|---|---|---|
| Radiomics on MRIThrough extracting and analyzing a large number of features from medical imaging, radiomics has shown promising results in treatment outcome prediction for many diseases including breast cancer (45-50). UTSW physics group has developed several new radiomic approaches and radiomic features, such as a multi-objective radiomics model(51) and a new radiomic "Shell" feature(52). As an exploratory end point for this trial, the investigators will explore the application radiomics using pre-treatment MRI, treatment parameters and clinical characteristics as input to predict pathological response of radiation therapy (XRT) based on pathology report of surgical tissues and local recurrence. | Radiation | – |
| microbubble CEUS Contrast Enhanced Ultrasound (CEUS)Microbubble Contrast non-FDA approved for route of administration | Drug | – |
Primary outcome
Single fraction pre-operative radiation
Time frame: 4 years
To determine efficacy of single fraction 30 Gy pre-operative radiation in early-stage ER+ breast cancer patients and determine pathologic complete response rate at 10-15 months after radiation. Patients that have not had a complete imaging response on MRI, OA, or on needle biopsy at 9 months will move onto a second fraction of PULSAR radiation of 8 Gy at 9-10 months. Surgery will be at 10-12 months for those with complete imaging response and negative needle biopsy. For those with residual disease surgery will be postponed to 12-15 months.
1 secondary outcome
Microbubble contrast
Time frame: 4 years
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 8 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Asal Rahimi, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radiomics on MRI and microbubble CEUS Contrast Enhanced Ultrasound (CEUS) in people with Breast Cancer, run by University of Texas Southwestern Medical Center at 1 site in United States.
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 12 inclusion and 15 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. 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 United States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Sarah Neufeld, MS (214-645-8525, sarah.hardee@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Single fraction pre-operative radiation (time frame: 4 years). 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 8 Jul 2026.