Comparison of the Clinical Value of WBMR and PET/MR with PET/CT and Standard Diagnostics in the Preoperative Staging of Breast Cancer

A comparative study of the clinical value of innovative whole-body imaging techniques WBMR and PET/MR versus PET/CT and the standard diagnostic pathway in the preoperative assessment of the stage of breast cancer in patients.

The Medical University of Bialystok, in collaboration with LOMiRT, invites you to participate in an innovative research project involving the most technologically advanced whole-body imaging studies for breast cancer patients.

Information for Breast Cancer Patients

Concerning statistics

Breast cancer is the most common malignant tumor among women in Poland and worldwide. In Poland in 2020, there were 17,511 reported cases, accounting for 23.8% of all malignant tumor cases. Breast cancer is the second leading cause of cancer-related deaths among women in our country, following lung cancer.

Both in Poland and across Europe, there is a steady increase in the incidence rate of cancer, including breast cancer. Given that we rank second in Europe in terms of breast cancer mortality, it is crucial to undertake specific actions to enhance the effectiveness of therapies. Potential reasons for high mortality rates include late detection of tumors and suboptimal therapy selection, often influenced by imprecise initial staging of advanced tumors.

It is undeniable that precise preoperative assessment of tumor staging during initial diagnostics, made possible mainly through innovative multiparametric imaging studies, forms the basis for successful therapeutic interventions.

Current imaging diagnostic standards aimed at ruling out distant metastases in breast cancer patients involve methods with relatively low sensitivity and specificity. These include chest X-rays, abdominal and pelvic ultrasounds. Many patients also undergo whole-body computed tomography (CT), which offers higher sensitivity and specificity compared to X-rays and ultrasounds, but significantly lower than PET/CT. However, CT exposes patients to high doses of ionizing radiation and requires contrast agents. Only ambiguous results from these tests justify proceeding to PET/CT scans. Yet, PET/CT is underutilized in preoperative diagnostics, despite its potential to alter staging in up to 37% of cases [12]. In cancer, time is crucial, and the current procedural requirements prolong the diagnostic process.

Whole-body MRI (WBMR) and PET/MR scans, despite their high sensitivity and specificity for whole-body assessment, are not included in the current list of reimbursed examinations. PET/MR offers a significant reduction in ionizing radiation exposure compared to PET/CT. Meanwhile, WBMR, which does not involve ionizing radiation, demonstrates high sensitivity (97%) and specificity (91%) in detecting metastatic breast cancer [13].

Sensitivity and specificity of individual imaging methods in detecting metastatic breast cancer*

Benefits for study participants

Each participant in the study will undergo PET/CT and PET/MR imaging. Participants in the research group will additionally receive WBMR (Whole Body Magnetic Resonance) imaging. These studies can enhance the accuracy of whole-body diagnostics to determine the extent of breast cancer and potential distant metastases, thereby directly impacting the establishment of appropriate and individualized therapeutic pathways for the participants.

The study conditions provide access to state-of-the-art imaging diagnostics for women across the entire country, regardless of their treatment location.

Qualification criteria for the study:

1. Preliminary diagnosis of breast cancer at stage IIA or higher according to TNM AJCC classification.
2. Good overall health status according to WHO criteria.
3. Initial standard diagnostic evaluation assessing the stage of the disease to qualify for appropriate therapy has been conducted.
4. Diagnosis based on cytological or histopathological examination.
5. No therapeutic intervention has been initiated.

Exclusion criteria from the study:

1. Presence of another malignant tumor in the patient.
2. Previous initiation of treatment for the primary disease.
3. Terminal condition of the patient.
4. Metal implants or foreign metal bodies preventing MRI examination on a 3T scanner.
5. Claustrophobia.
6. Body weight that prevents PET/MR examination.
7. Lack of patient cooperation preventing the completion of lengthy imaging studies.
8. Pregnancy or breastfeeding.

Conditions for participation in the project:

1. Contact BioSkaner directly in person, by phone, or by email.
2. Our staff will conduct qualification assessments based on the criteria listed above.
3. Arrange a visit with a nuclear medicine specialist at the BioSkaner clinic located at ul. Żurawia 71a in Białystok.
4. Within 7 days of the screening visit and qualification for the project, the procedure for whole-body imaging examinations as outlined in the Project will commence.
5. After the examination, the patient will promptly receive saved images, and once reviewed by physicians, a description of the examination in electronic form. The report will be sent to the patient’s specified mailing address or email.

Proper preoperative diagnostics should form the basis for selecting the most appropriate therapeutic option. However, the condition is to use research methods at the highest level of technological advancement. According to the above data, despite significant technological progress, current reimbursement procedures do not cover the use of the latest imaging methods and nuclear medicine advancements. Ultimately, this limits the optimization and individualization of patient therapy.

Contact information:

phone number: 85 500 10 21

email: pet-rejestracja@bioskaner.eu

Bibliography:

1. European Cancer Information System https://ecis.jrc.ec.europa.eu/2020.
2. Petralia G., Koh DM et al. Oncologically Relevant Findings Reporting and Data System (ONCO-RADS): Guidelines for the Acquisition, Interpretation, and Reporting of Whole-Body MRI for Cancer Screening. Radiology. 2021 Jun;299(3):494-507.
3. Webber C., Jiang L et al. Identifying predictors of delayed diagnoses in symptomatic breast cancer: a scoping review. Eur. J. Cancer. 2017 Mar;26(2).
4. Mendonca SC., Abel G et al. Pre-referral general practitioner consultations and subsequent experience of cancer care: evidence from the English Cancer Patient Experience Survey. Eur. J. Cancer Care (Engl.). 2016 May;25(3):478-90.
5. Richards MA., Westcombe AM et al. Influence of delay on survival in patients with breast cancer: a systematic review. Lancet. 1999 Apr 3;353(9159):1119-26.
6. Harbeck N., Penault-Llorca F et al. Breast cancer. Nat Rev Dis Primers. 2019 Sep 23;5(1):66.
7. American Cancer Society https:// www.cancer.org/research/cancer-facts-statistics/2015.
8. Groheux D., Hindie E. Breast cancer: initial workup and staging with FDG PET/CT. Clin Transl Imaging. 2021;9(3):221-231.
9. Correa P., Cutter C et al. Effect of radiotherapy after mastectomy and axillary surgery on 10-year recurrence and 20-year breast cancer mortality: Meta-analysis of individual patient data for 8135 women in 22 randomised trials. Lancet. 2014 Nov 22;384(9957):1848.
10. Krajowy Rejestr Nowotworów http://onkologia.org.pl/ 2019.
11. Jassem J., Krzakowski M et al. Breast cancer. Oncol Clin Pract 2018;14.
12. Cochet A., Dygai-Cochet I et al. 18F-FDG PET/CT provides powerful prognostic stratification in the primary staging of large breast cancer when compared with conventional explorations. Eur J Nucl Med Mol Imaging. 2014 Mar;41(3):428-37.
13. Gutzeit A., Doert A et al. Comparison of diffusion weighted whole body MRI and skeletal scintigraphy for the detection of bone metastases in patients with prostate or breast carcinoma. SkeletalRadiol. 2010;39:333–343.
14. Catalano OA., Daye D et al. Staging performance of wholebody DWI, PET/CT and PET/MRI in invasive ductal carcinoma of the breast. Int J Oncol. 2017;51:281–288.
15. Catalano OA., Nicolai E et al. Comparison of CE-FDG-PET/CT with CE-FDG-PET/MR in the evaluation of osseous metastases in breast cancer patients. Br J Cancer. 2015;112:1452–1460.
16. Bruckmann NM., Sawicki LM et al. Prospective evaluation of whole-body MRI and 18F-FDG PET/MRI in N and M staging of primary breast cancer patients. Eur J Nucl Med Mol Imaging. 2020 Nov;47(12):2816-2825.
17. Shen G., Deng H et al. Comparison of choline-PET/CT, MRI, SPECT, and bone scintigraphy in the diagnosis of bone metastases in patients with prostate cancer: a meta-analysis. Skeletal Radiol. 2014;43:1503–1513.
18. Pesapane F., Downey K et al. Imaging diagnosis of metastatic breast cancer. Insights Imaging. 2020 Jun 16;11(1):79.
19. Schmidt GP., Reiser MF et al. Whole-body MRI for the staging and follow-up of patients with metastasis. Eur J Radiol. 2009 Jun;70(3):393-400.
20. Antoch G., Vogt FM et al. Whole-body dual-modality PET/CT and whole-body MRI for tumor staging in oncology. JAMA. 2003 Dec 24;290(24):3199-206.
21. Melsaether AN., Raad RA et al. 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;281:193–202.
22. Minamimoto R., Loening A et al. Prospective comparison of 99mTc-MDP scintigraphy, combined 18F-NaF and 18F-FDG PET/CT, and whole-body MRI in patients with breast and prostate cancer. J Nucl Med. 2015 Dec;56(12):1862-8.
23. Birim O., Kappetein AP et al. Meta-analysis of positron emission tomographic and computed tomographic imaging in detecting mediastinal lymph node metastases in nonsmall cell lung cancer. Ann Thorac Surg. 2005 Jan;79(1):375-82.
24. Brennan ME., Houssami N et al. Evaluation of the evidence on staging imaging for detection of asymptomatic distant metastases in newly diagnosed breast cancer. Breast. 2012 Apr; 21(2):112-23.
25. Pesapane F., Downey K et al. Imaging diagnosis of metastatic breast cancer. Insights Imaging. 2020 Jun 16;11(1):79.
26. Heindel W., Gubitz R et al. The diagnostic imaging of bone metastases. Dtsch Arztebl Int. 2014;111:741–747.