An interventional study of Serial MAMMI-BB PET Imaging in Breast Cancer, Neoadjuvant Therapy and Axilla; Breast, sponsored by Fudan University. Active, not recruiting at 1 site in China. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Fudan University · Not applicable, Interventional, and Diagnostic
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.
12,820 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 1,024 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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.
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.
Diagnostic Test: Serial MAMMI-BB PET Imaging
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.
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.
Time frame: From baseline through definitive surgery, up to 8 months
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.
Time frame: 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.
Time frame: 5 years
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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