Clinical trial · Interventional
FDG PET and DCE-MRI in Predicting Response to Treatment in Patients With Breast Cancer
Quantitative Dynamic PET and MRI and Breast Cancer Therapy
NCT01931709CI-TRIAL-00071514terminatedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Terminated due to end of funding
Summary
Brief summary (as posted)
This clinical trial studies fludeoxyglucose F 18 (FDG) positron emission tomography (PET) and dynamic contrast-enhanced (DCE)-magnetic resonance imaging (MRI) in predicting response to treatment in patients with breast cancer. Comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dynamic contrast-enhanced magnetic resonance imaging | Device | — | UNRESOLVED |
| fludeoxyglucose F 18 | Radiation | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| positron emission tomography | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diagnostic (FDG PET and DCE-MRI)
- description
- Patients undergo FDG PET and DCE-MRI 1-2 weeks prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).
- interventionNames
- Radiation: fludeoxyglucose F 18
- Device: positron emission tomography
- Device: dynamic contrast-enhanced magnetic resonance imaging
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Number of Participants With Favorable Pathologic Response at Surgery
- timeFrame
- At time of surgery
- description
- The primary clinical endpoint is dichotomous (yes/no) - Has patient achieved favorable microscopic pathologic response at surgery? This favorable pathologic response is defined as: 1. No evidence of microscopic invasive tumor at the primary tumor site and in regional axillary lymph nodes = Residual Cancer Burden class 0 (RCB 0) 2. Minimal invasive residual disease at primary tumor site and/or in regional axillary lymph nodes = Residual Cancer Burden class I (RCB I)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy * Primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable N1 or N2 or biopsy proven) * No obvious contraindications for primary chemotherapy * Able to lie still for PET and MRI scanning * Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines Exclusion Criteria: * Serious systemic illness other than breast cancer * Contraindication to MRI or history of adverse reaction to gadolinium * Evidence of distant disease outside of regional lymph nodes * Pregnant * Poorly controlled diabetes mellitus (fasting blood glucose \> 200) * Prior systemic cancer therapy
References
Publications (1)
- DERIVEDKazerouni AS, Peterson LM, Jenkins I, Novakova-Jiresova A, Linden HM, Gralow JR, Hockenbery DM, Mankoff DA, Porter PL, Partridge SC, Specht JM. Multimodal prediction of neoadjuvant treatment outcome by serial FDG PET and MRI in women with locally advanced breast cancer. Breast Cancer Res. 2023 Nov 9;25(1):138. doi: 10.1186/s13058-023-01722-4. PMID 37946201