Breast CancerMAMMI-PREDICTNCT07875244
MAMMI-BB PET for Monitoring Response to Neoadjuvant Therapy in Breast Cancer
A study testing Serial MAMMI-BB PET Imaging in people with Breast Cancer and Neoadjuvant Therapy, run by Fudan University at 1 site in China.
Trial summary
This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph node involvement. Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer, Neoadjuvant Therapy, Axilla; Breast
- What is being tested?
- Serial MAMMI-BB PET Imaging
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,024 participants
- Where
- 1 siteChina
- Study dates
- 27 Jun 2019to May 2027
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary invasive breast carcinoma confirmed by core needle biopsy of the breast lesion.
- Clinical stage cT1-4N0-3M0.
- Age 18 to 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Hepatic, renal, and cardiac function adequate to tolerate chemotherapy and targeted therapy, as applicable.
- Planned neoadjuvant chemotherapy with or without targeted therapy.
- Provision of informed consent before study participation.
Who cannot join
- Pregnancy or breastfeeding.
- Previous surgery or radiotherapy involving the ipsilateral axillary lymph nodes.
- Diabetes mellitus or allergy to the radiotracer rendering the patient unsuitable for 18F-FDG PET/CT examination.
- A history of, or concurrent, malignancy other than breast cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix, or another malignancy considered cured with no evidence of recurrence for at least 5 years.
- Psychiatric illness or another condition affecting compliance with study requirements.
- Serious disease or medical conditions, including:- Congestive heart failure, unstable angina, myocardial infarction within 6 months before enrollment, hypertension considered uncontrolled by the investigator, or high-risk uncontrolled arrhythmia.
Show all 10Show fewer
- Significant neurological or psychiatric disorders that may impair understanding or provision of informed consent.
- Uncontrolled acute infection.
- An allergic predisposition or known or suspected allergy to any study medication.
- Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Evaluating MAMMI-BB (Biplanar Breast) PET for Serial Monitoring of Response to Neoadjuvant Therapy in Breast Cancer
This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph node involvement. Serial PET examinations will measure changes in maximum standardized uptake value (SUVmax) in breast lesions and axillary lymph nodes. These changes will be compared with surgical pathology to assess their ability to predict pathologic complete response separately in the breast and axilla and to identify the most informative assessment time point. Associations between PET parameters and long-term outcomes, including progression-free survival and disease-free survival, will also be explored.
- Conditions
- Breast Cancer, Neoadjuvant Therapy, Axilla; Breast
- Being tested
- Serial MAMMI-BB PET Imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Serial MAMMI-BB PET ImagingDiagnostic test
Serial fluorine-18 fluorodeoxyglucose (18F-FDG) PET imaging of the breast and axilla using MAMMI-BB PET. Participants fast for at least 4 hours, undergo blood glucose and body weight measurements, and receive intravenous 18F-FDG. Imaging begins approximately 60 minutes after injection. Breast imaging is performed in the prone position, followed by axillary imaging in the standing position with the arm supported. SUVmax is measured separately in breast lesions and axillary lymph nodes at four planned assessment time points.
| Study group | Role | What they receive |
|---|---|---|
| Serial MAMMI-BB PET Assessment | Experimental | Breast cancer participants with or without baseline axillary lymph node involvement will undergo serial MAMMI-BB PET imaging before and during neoadjuvant therapy. PET parameters will be compared with surgical pathology to evaluate prediction of pathologic complete response in the breast and axilla. Receives: Diagnostic Test: Serial MAMMI-BB PET Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Accuracy of Serial Changes in Breast Lesion SUVmax for Predicting Breast and Nodal Pathologic Complete Response
The ability of relative changes in breast and axillary lesion SUVmax from baseline to the early, intermediate, and end-of-neoadjuvant-treatment assessments to predict breast pathologic complete response will be evaluated using postoperative histopathology as the reference standard. ROC analysis and estimates of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy with 95% confidence intervals will be used.
Measured: From baseline through definitive surgery, up to 8 months
Secondary outcomes (2)
Progression-Free Survival
Time from enrollment to first documented disease progression or death from any cause, whichever occurs first. Tumor progression will be assessed according to RECIST version 1.1 during neoadjuvant therapy and by documented recurrence during follow-up. The correlation between serial MAMMI-BB PET SUVmax parameters and progression-free survival will be explored using Cox proportional hazards models.
Measured: 5 years
Disease-Free Survival
Time from definitive surgery to first documented local, regional, or distant recurrence, or death from any cause, whichever occurs first. The correlation between serial MAMMI-BB PET SUVmax parameters and disease-free survival will be explored using Cox proportional hazards models.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start27 Jun 2019
- Primary completionOct 2026 (estimated)
- Study completionMay 2027 (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 Fudan UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,024 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhimin Shao, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07875244
- Sponsor's protocol ID
- 1912212-3
- Acronym
- MAMMI-PREDICT
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Evaluating MAMMI-BB (Biplanar Breast) PET for Serial Monitoring of Response to Neoadjuvant Therapy in Breast Cancer
- ClinicalTrials.gov ID
- NCT07875244
- Acronym / sponsor ID
- MAMMI-PREDICT / 1912212-3
- Conditions
- Breast Cancer, Neoadjuvant Therapy, Axilla; Breast
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,024 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 27 Jun 2019 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 15 Oct 2026 (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.
This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph node involvement. Serial PET examinations will measure changes in maximum standardized uptake value (SUVmax) in breast lesions and axillary lymph nodes. These changes will be compared with surgical pathology to assess their ability to predict pathologic complete response separately in the breast and axilla and to identify the most informative assessment time point. Associations between PET parameters and long-term outcomes, including progression-free survival and disease-free survival, will also be explored.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Serial MAMMI-BB PET Assessment | Experimental | Diagnostic Test: Serial MAMMI-BB PET ImagingBreast cancer participants with or without baseline axillary lymph node involvement will undergo serial MAMMI-BB PET imaging before and during neoadjuvant therapy. PET parameters will be compared with surgical pathology to evaluate prediction of pathologic complete response in the breast and axilla. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Primary invasive breast carcinoma confirmed by core needle biopsy of the breast lesion.
- Clinical stage cT1-4N0-3M0.
- Age 18 to 70 years.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- Hepatic, renal, and cardiac function adequate to tolerate chemotherapy and targeted therapy, as applicable.
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding.
- Previous surgery or radiotherapy involving the ipsilateral axillary lymph nodes.
- Diabetes mellitus or allergy to the radiotracer rendering the patient unsuitable for 18F-FDG PET/CT examination.
- A history of, or concurrent, malignancy other than breast cancer, except non-melanoma skin cancer, carcinoma in situ of the cervix, or another malignancy considered cured with no evidence of recurrence for at least 5 years.
- Psychiatric illness or another condition affecting compliance with study requirements.
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 |
|---|---|---|
| Serial MAMMI-BB PET ImagingSerial fluorine-18 fluorodeoxyglucose (18F-FDG) PET imaging of the breast and axilla using MAMMI-BB PET. Participants fast for at least 4 hours, undergo blood glucose and body weight measurements, and receive intravenous 18F-FDG. Imaging begins approximately 60 minutes after injection. Breast imaging is performed in the prone position, followed by axillary imaging in the standing position with the arm supported. SUVmax is measured separately in breast lesions and axillary lymph nodes at four planned assessment time points. | Diagnostic test | Serial MAMMI-BB PET Assessment |
Primary outcome
Diagnostic Accuracy of Serial Changes in Breast Lesion SUVmax for Predicting Breast and Nodal Pathologic Complete Response
Time frame: From baseline through definitive surgery, up to 8 months
The ability of relative changes in breast and axillary lesion SUVmax from baseline to the early, intermediate, and end-of-neoadjuvant-treatment assessments to predict breast pathologic complete response will be evaluated using postoperative histopathology as the reference standard. ROC analysis and estimates of sensitivity, specificity, positive predictive value, negative predictive value, and diagnostic accuracy with 95% confidence intervals will be used.
2 secondary outcomes
Progression-Free Survival
Time frame: 5 years
Disease-Free Survival
Time frame: 5 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 15 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Serial MAMMI-BB PET Imaging in people with Breast Cancer and Neoadjuvant Therapy, run by Fudan University at 1 site in China.
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 7 inclusion and 10 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 15 Oct 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 China. 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?
Diagnostic Accuracy of Serial Changes in Breast Lesion SUVmax for Predicting Breast and Nodal Pathologic Complete Response (time frame: From baseline through definitive surgery, up to 8 months). 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 15 Oct 2026.