Breast Cancer Female Clinical Trial
Official title:
Targeting the Future of Axillary Staging in Node Positive Breast Cancer Patients Receiving Primary Systemic Therapy. A Comparative Study Between Sentinel Node Biopsy vs PET/MRI.
The management of axillary nodes in breast cancer patients is a highly debated and evolving field. To date, an increasing number of patients with positive lymph nodes receives primary systemic therapy (PST) prior to surgery leading to down-staging axillary nodes in about 40% of women. However, the available diagnostic methods have several limitations in properly evaluating the response after treatment both in the breast and in the nodes and might lead to either under or over-treatment in these patients. Fully integrated scanners capable of simultaneous acquisition of PET and MRI have now been developed, with the potential to combine the specificity obtained by the functional imaging of PET, with the superior sensitivity of MRI, to provide higher diagnostic accuracy. It is expected that PET/MRI could better determine the response after PST to distinguish patients with negative versus patients with positive axillary nodes after medical treatment. As the excision of axillary nodes has mainly a staging purpose, the reliable identification of node negative patients might eventually spare women from unnecessary surgery. An accurate over-time and final imaging work-up might help choose the appropriate type of surgery according to the extent of nodal involvement: either SNB or complete axillary clearance.
Status | Recruiting |
Enrollment | 110 |
Est. completion date | December 1, 2024 |
Est. primary completion date | April 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Signed informed consent; - Age > 18 years; - Proven diagnosis of early BC of any size; - Patients candidate to primary systemic therapy (PST); - Positive axillary nodes at diagnosis, confirmed by either citology or histology confirmation. Patients with clear overt clinical and radiological nodal involvement might be enrolled as well without FNA or microhystology Exclusion Criteria: - inflammatory BC; - pregnancy; - contraindication to PET; - distant metastases; - no surgery after PST; - contraindication to MRI; - claustrophobia; - allergy to the MR contrast agent; - severe renal insufficiency. |
Country | Name | City | State |
---|---|---|---|
Italy | Ospedale San Raffaele | Milano | MI |
Lead Sponsor | Collaborator |
---|---|
Oreste Davide Gentilini | IBFM- Consiglio Nazionale delle Ricerche |
Italy,
Gentilini O, Veronesi U. Staging the Axilla in Early Breast Cancer: Will Imaging Replace Surgery? JAMA Oncol. 2015 Nov;1(8):1031-2. doi: 10.1001/jamaoncol.2015.2337. No abstract available. — View Citation
Heusch P, Nensa F, Schaarschmidt B, Sivanesapillai R, Beiderwellen K, Gomez B, Kohler J, Reis H, Ruhlmann V, Buchbender C. Diagnostic accuracy of whole-body PET/MRI and whole-body PET/CT for TNM staging in oncology. Eur J Nucl Med Mol Imaging. 2015 Jan;42(1):42-8. doi: 10.1007/s00259-014-2885-5. Epub 2014 Aug 12. — View Citation
Melsaether AN, Raad RA, Pujara AC, Ponzo FD, Pysarenko KM, Jhaveri K, Babb JS, Sigmund EE, Kim SG, Moy LA. Comparison of Whole-Body (18)F FDG PET/MR Imaging and Whole-Body (18)F FDG PET/CT in Terms of Lesion Detection and Radiation Dose in Patients with Breast Cancer. Radiology. 2016 Oct;281(1):193-202. doi: 10.1148/radiol.2016151155. Epub 2016 Mar 29. — View Citation
Stadnik TW, Everaert H, Makkat S, Sacre R, Lamote J, Bourgain C. Breast imaging. Preoperative breast cancer staging: comparison of USPIO-enhanced MR imaging and 18F-fluorodeoxyglucose (FDC) positron emission tomography (PET) imaging for axillary lymph node staging--initial findings. Eur Radiol. 2006 Oct;16(10):2153-60. doi: 10.1007/s00330-006-0276-4. Epub 2006 May 3. — View Citation
Taneja S, Jena A, Goel R, Sarin R, Kaul S. Simultaneous whole-body (1)(8)F-FDG PET-MRI in primary staging of breast cancer: a pilot study. Eur J Radiol. 2014 Dec;83(12):2231-2239. doi: 10.1016/j.ejrad.2014.09.008. Epub 2014 Sep 28. — View Citation
van Nijnatten TJA, Goorts B, Voo S, de Boer M, Kooreman LFS, Heuts EM, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Added value of dedicated axillary hybrid 18F-FDG PET/MRI for improved axillary nodal staging in clinically node-positive breast cancer patients: a feasibility study. Eur J Nucl Med Mol Imaging. 2018 Feb;45(2):179-186. doi: 10.1007/s00259-017-3823-0. Epub 2017 Sep 14. — View Citation
Veronesi U, De Cicco C, Galimberti VE, Fernandez JR, Rotmensz N, Viale G, Spano G, Luini A, Intra M, Veronesi P, Berrettini A, Paganelli G. A comparative study on the value of FDG-PET and sentinel node biopsy to identify occult axillary metastases. Ann Oncol. 2007 Mar;18(3):473-8. doi: 10.1093/annonc/mdl425. Epub 2006 Dec 12. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Axillary surgery vs PET/MRI. | Results from SNB (Sentinel Node Biopsy), AD (Axillary Dissection) or any axillary surgery will be compared to results from preoperative PET/MRI. | Within 1 month after surgery results from axillary surgery will be available and compared to preoperative PET/MRI | |
Secondary | Staging power of PET/MRI will be compared to preoperative A-US (Axillary ultrasound) | Results on the status of axillary nodes from preoperative A-US will be compared to results of preoperative PET/MRI. | At 12 months | |
Secondary | Correlation between PET/MRI parameters and prognosis | Quantitative analysis of PET/MRI exams will allow to extract standard imaging biomarkers to be correlated with tumour clinical and pathological data. Image analysis will be carried out both at staging and at the end of PST.
Functional parameters from PET image analysis include Standardized Uptake Value and Metabolic Tumor Volume. From breast MR images, the quantitative and semiquantitative data are related to DWI and DCE MR sequences. Specifically, from the so-called Time Intensity Curve (TIC) obtained from the dynamic DCE some parameters can be extracted, for example Time To Peak, Peak Enhancement Percentage, Signal Enhancement Ratio and Initial Enhancement Percentage. From DWI MR sequence Apparent Diffusion Coefficient map can be calculated. |
At baseline and at 5 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03080623 -
Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
|
||
Completed |
NCT05527769 -
Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
|
||
Completed |
NCT06376578 -
Exercise Interventions for Improving Health in Breast Cancer Survivors
|
N/A | |
Completed |
NCT03004534 -
A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide
|
Early Phase 1 | |
Recruiting |
NCT05020574 -
Microbiome and Association With Implant Infections
|
Phase 2 | |
Active, not recruiting |
NCT06277141 -
The Vitality Mammography Messaging Study
|
N/A | |
Completed |
NCT03270111 -
High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women
|
N/A | |
Completed |
NCT03555227 -
USG PECS vs LIA for Breast Cancer Surgery
|
N/A | |
Active, not recruiting |
NCT03917082 -
Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer
|
Phase 2 | |
Recruiting |
NCT05561842 -
Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
|
||
Completed |
NCT04554056 -
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
|
Phase 2/Phase 3 | |
Active, not recruiting |
NCT03127995 -
Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence
|
N/A | |
Active, not recruiting |
NCT02237469 -
Prone Breast Radiotherapy Treatment Planning Observational Study
|
||
Completed |
NCT01204125 -
Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients
|
Phase 2 | |
Recruiting |
NCT04565054 -
Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC
|
Phase 3 | |
Not yet recruiting |
NCT06412133 -
Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients
|
N/A | |
Recruiting |
NCT03956641 -
Evolution of the Physical Condition in Treated Cancer Patients
|
N/A | |
Recruiting |
NCT06087120 -
Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
|
||
Recruiting |
NCT06058936 -
Exercises Using Virtual Reality on Cancer Patients
|
N/A | |
Completed |
NCT03470935 -
Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
|