Fluorocholine PET/MR in Breast Cancer

NCT07587086 | Recruiting DMC

• 1 other identifier: 2020-03-005A
• Study Type: observational
• Target: 195
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Our study is conducted to use the pre-treatment FCH PET/MR in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes. Primary study purposes:

1. 1.Women aged 25-75 years old.
2. 2.Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
3. 3.Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.

Conditions

Breast Neoplasms; Female

Keywords

Breast Cancer; FCH(18F- Fluorocholine); Radiomics; PET/MRI

Outcome Measures

Primary Outcomes (1)

• Whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose.

  To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with molecular subtypes of breast cancers, and to evaluate the diagnostic performance for prediction purpose

  From enrollment to the end of study (follow up) at least 40 weeks

Secondary Outcomes (1)

• To investigate whether the pre-treatment FCH PET/MR imaging parameters are associated with the factors related to clinical outcomes (histologic grade, prognosis) and to analyze which parameters are more accurate for prediction purposes.

  From enrollment, at least about 40 weeks (until the completion of chemotherapy, or when the surgical pathology comes out).

Study Arms (1)

Single arm

Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).

Diagnostic Test: PET-MRI

Interventions

PET-MRI DIAGNOSTIC_TEST

1. The study participants will receive pre-treatment whole body PET/MR and breast PET/MR examinations. 2. The whole body PET/MR 3. PET/MR of the breast 4. The whole body FDG PET/MR, and the breast FCH PET/MR will be performed on different days (interval \>= 2 days). 5. The study results will be interpreted by board certified diagnostic radiologists and nuclear medicine physicians, and relayed to the patient's physicians for reference of clinical management.

Single arm

Eligibility Criteria

• Age: 25 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study is conducted to use the pre-treatment FCH PET/MR in breast cancer patients, to investigate whether the conventional PET/MR imaging markers (SUVmax, MR spectroscopy-derived choline analysis, dynamic contrast-enhanced MRI, ADC analysis), and FCH/MR radiomic features, deep learning (DL) analysis are associated with molecular subtypes, clinical outcomes, treatment response, survival, and which parameters are more accurate for prediction purposes.

You may qualify if:

• Women aged 25-75 years old.
• Women diagnosed as breast cancer by pathological diagnosis from core biopsy within 3 months and who will receive neoadjuvant chemotherapy (NAC) before surgery; or women with pathologically proven breast cancer within 3 months and who will receive operation (without pre-operative neoadjuvant chemotherapy).
• Women whose ECOG between 0-2 points and life expectancy ≧ 3 months.

You may not qualify if:

• Women who are unable to cooperate with the examinations
• Women who are pregnant, lactating or are planning to be pregnant
• Women with estimated GFR (eGFR) \< 60 ml/min/1.73m2 or acute renal failure within 3 months, past history of renal dialysis.
• Past history of claustrophobia
• Past history of anaphylactoid reactions to MRI contrast agents or PET tracer agents.
• Women with cardiac pacemaker, aneurysmal clip, mechanical valve replacement, recently applied coronary artery stent (\<3 months).
• Past history of breast cancer or other malignancy within 5 years.
• Women who underwent chemotherapy within a year.
• Women who are not suitable to join the study according to the assessment by investigators.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, Taiwan, 11217, Taiwan

RECRUITING

Related Publications (10)

• Pujara AC, Kim E, Axelrod D, Melsaether AN. PET/MRI in Breast Cancer. J Magn Reson Imaging. 2019 Feb;49(2):328-342. doi: 10.1002/jmri.26298. Epub 2018 Oct 6.

  PMID: 30291656 BACKGROUND

• Grueneisen J, Nagarajah J, Buchbender C, Hoffmann O, Schaarschmidt BM, Poeppel T, Forsting M, Quick HH, Umutlu L, Kinner S. Positron Emission Tomography/Magnetic Resonance Imaging for Local Tumor Staging in Patients With Primary Breast Cancer: A Comparison With Positron Emission Tomography/Computed Tomography and Magnetic Resonance Imaging. Invest Radiol. 2015 Aug;50(8):505-13. doi: 10.1097/RLI.0000000000000197.

  PMID: 26115367 BACKGROUND

• Goorts B, Voo S, van Nijnatten TJA, Kooreman LFS, de Boer M, Keymeulen KBMI, Aarnoutse R, Wildberger JE, Mottaghy FM, Lobbes MBI, Smidt ML. Hybrid 18F-FDG PET/MRI might improve locoregional staging of breast cancer patients prior to neoadjuvant chemotherapy. Eur J Nucl Med Mol Imaging. 2017 Oct;44(11):1796-1805. doi: 10.1007/s00259-017-3745-x. Epub 2017 Jun 10.

  PMID: 28600647 BACKGROUND

• Botsikas D, Bagetakos I, Picarra M, Da Cunha Afonso Barisits AC, Boudabbous S, Montet X, Lam GT, Mainta I, Kalovidouri A, Becker M. What is the diagnostic performance of 18-FDG-PET/MR compared to PET/CT for the N- and M- staging of breast cancer? Eur Radiol. 2019 Apr;29(4):1787-1798. doi: 10.1007/s00330-018-5720-8. Epub 2018 Sep 28.

  PMID: 30267154 BACKGROUND

• Jena A, Taneja S, Singh A, Negi P, Sarin R, Das PK, Singhal M. Reliability of 18F-FDG PET Metabolic Parameters Derived Using Simultaneous PET/MRI and Correlation With Prognostic Factors of Invasive Ductal Carcinoma: A Feasibility Study. AJR Am J Roentgenol. 2017 Sep;209(3):662-670. doi: 10.2214/AJR.16.17766. Epub 2017 Jul 5.

  PMID: 28678576 BACKGROUND

• Cho N, Im SA, Cheon GJ, Park IA, Lee KH, Kim TY, Kim YS, Kwon BR, Lee JM, Suh HY, Suh KJ. Integrated 18F-FDG PET/MRI in breast cancer: early prediction of response to neoadjuvant chemotherapy. Eur J Nucl Med Mol Imaging. 2018 Mar;45(3):328-339. doi: 10.1007/s00259-017-3849-3. Epub 2017 Nov 4.

  PMID: 29101445 BACKGROUND

• Wang J, Shih TT, Yen RF. Multiparametric Evaluation of Treatment Response to Neoadjuvant Chemotherapy in Breast Cancer Using Integrated PET/MR. Clin Nucl Med. 2017 Jul;42(7):506-513. doi: 10.1097/RLU.0000000000001684.

  PMID: 28481792 BACKGROUND

• Li H, Zhu Y, Burnside ES, Huang E, Drukker K, Hoadley KA, Fan C, Conzen SD, Zuley M, Net JM, Sutton E, Whitman GJ, Morris E, Perou CM, Ji Y, Giger ML. Quantitative MRI radiomics in the prediction of molecular classifications of breast cancer subtypes in the TCGA/TCIA data set. NPJ Breast Cancer. 2016;2:16012. doi: 10.1038/npjbcancer.2016.12. Epub 2016 May 11.

  PMID: 27853751 BACKGROUND

• Li H, Zhu Y, Burnside ES, Drukker K, Hoadley KA, Fan C, Conzen SD, Whitman GJ, Sutton EJ, Net JM, Ganott M, Huang E, Morris EA, Perou CM, Ji Y, Giger ML. MR Imaging Radiomics Signatures for Predicting the Risk of Breast Cancer Recurrence as Given by Research Versions of MammaPrint, Oncotype DX, and PAM50 Gene Assays. Radiology. 2016 Nov;281(2):382-391. doi: 10.1148/radiol.2016152110. Epub 2016 May 5.

  PMID: 27144536 BACKGROUND

• Guo W, Li H, Zhu Y, Lan L, Yang S, Drukker K, Morris E, Burnside E, Whitman G, Giger ML, Ji Y; Tcga Breast Phenotype Research Group. Prediction of clinical phenotypes in invasive breast carcinomas from the integration of radiomics and genomics data. J Med Imaging (Bellingham). 2015 Oct;2(4):041007. doi: 10.1117/1.JMI.2.4.041007. Epub 2015 Sep 23.

  PMID: 26835491 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Jane Wang, M.D.

CONTACT

+886938591583; jwang2@vghtpe.gov.tw

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 40 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2026
• First Posted: May 14, 2026
• Study Start: June 14, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)