Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET

Официальное название

Improving Detection and Outcomes in Patients With Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAPI PET Imaging

Обзор

This study is a pilot clinical imaging trial of a prospective, head-to-head comparison of 18F-Fibroblast Activation Protein Inhibitor (FAPI)-74 PET/CT versus standard-of-care 18F-Fluorodeoxyglucose (FDG) PET/CT in 15 patients with metastatic invasive lobular breast cancer (ILC). Patients will undergo both 18F-FDG PET/CT and 18F-FAPI-74 PET/CT within a 2-week period (14 days + 7 days) to compare lesions, tumor detection rates, and PET lesion intensity, as well as to assess the clinical value of the PET scans from the treating physician's and the patient's perspective.

Вмешательства

• Препарат 18F-FAPI-74
  FAPI scans will be performed as hybrid PET/CT examinations for attenuation correction and lesion localization. Each patient will be injected intravenously with 7 mCi +/- 2 mCi of 18F-FAPI-74 followed by a 20-minute (+/-10 min) uptake period.
• Препарат 18F-FDG
  FDG PET/CT will be performed per standard-of-care protocol at Mount Sinai Hospital. Patients will fast for at least 6 hours before FDG administration and plasma glucose levels will be checked to ensure \< 200 mg/dL. Each patient will be injected intravenously with 15 mCi +/- 20% of 18F-FDG.
• Процедура PET/CT
  FAPI PET/CT images will be acquired from the top of skull to mid-thigh. FDG PET/CT images will be acquired from the skull base to mid-thigh after a 60-min uptake period. Outside FDG PET/CT performed at another institutional can be accepted, if image quality and acquisition is comparable to standard-of-care protocol at Mount Sinai Hospital.

Первичные конечные точки

• Proportion of lesions detected by 18F-FAPI-74 PET/CT [Срок оценки: End of study, at 1 month]

Вторичные конечные точки (7)

• Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT [Срок оценки: End of study, at 1 month]
• Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT [Срок оценки: End of study, at 1 month]
• Tumor detection rate [Срок оценки: End of study, at 1 month]
• SUVmax of the hottest lesion (lesion with highest SUVmax) on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT and mean SUVmax across all lesions [Срок оценки: End of study, at 1 month]
• Tumor-to-background ratio (TBR) [Срок оценки: End of study, at 1 month]
• Number of participants with change in therapeutic management decisions [Срок оценки: End of study, at 1 month]
• Change in disease status assessment [Срок оценки: End of study, at 1 month]

Критерии участия

Критерии включения

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
• Females; Age > 18 years of age
• Diagnosis of invasive lobular breast cancer, with pathologically confirmed metastatic disease.
• ECOG performance status 0-2
• No planned change in anticancer therapy between FDG and FAPI PET scans

Критерии исключения

• Patients who are pregnant or lactating
• Patients who cannot undergo PET/CT scanning
• Patients with total serum bilirubin or serum creatinine > 1.5 times the upper limit of normal

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• Icahn School of Medicine at Mount Sinai — New York

Публикации

• Choi ES, Oh AY, In CB, Ryu JH, Jeon YT, Kim HG. Effects of recruitment manoeuvre on perioperative pulmonary complications in patients undergoing robotic assisted radical prostatectomy: A randomised single-blinded trial. PLoS One. 2017 Sep 6;12(9):e0183311. doi: 10.1371/journal.pone.0183311. eCollection 2017. PMID 28877238
• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8. PMID 31912902
• Fischer S, Dethlefsen S, Klockgether J, Tummler B. Phenotypic and Genomic Comparison of the Two Most Common ExoU-Positive Pseudomonas aeruginosa Clones, PA14 and ST235. mSystems. 2020 Dec 8;5(6):e01007-20. doi: 10.1128/mSystems.01007-20. PMID 33293405
• Davis AA, Gerratana L, Clifton K, Medford AJ, Velimirovic M, Hensing WL, Bucheit L, Shah AN, D'Amico P, Reduzzi C, Zhang Q, Dai CS, Denault EN, Bagegni NA, Opyrchal M, Ademuyiwa FO, Bose R, Gradishar WJ, Behdad A, Ma CX, Bardia A, Cristofanilli M. Circulating tumour DNA characterisation of invasive lobular carcinoma in patients with metastatic breast cancer. EBioMedicine. 2022 Dec;86:104316. doi: PMID 36332363
• Dumans-Nizard V, Le Guen M, Sage E, Chazot T, Fischler M, Liu N. Thoracic Epidural Analgesia With Levobupivacaine Reduces Remifentanil and Propofol Consumption Evaluated by Closed-Loop Titration Guided by the Bispectral Index: A Double-Blind Placebo-Controlled Study. Anesth Analg. 2017 Aug;125(2):635-642. doi: 10.1213/ANE.0000000000001996. PMID 28537969
• Benham-Hutchins MM, Effken JA. Multi-professional patterns and methods of communication during patient handoffs. Int J Med Inform. 2010 Apr;79(4):252-67. doi: 10.1016/j.ijmedinf.2009.12.005. Epub 2010 Jan 15. PMID 20079686
• Niikura N, Costelloe CM, Madewell JE, Hayashi N, Yu TK, Liu J, Palla SL, Tokuda Y, Theriault RL, Hortobagyi GN, Ueno NT. FDG-PET/CT compared with conventional imaging in the detection of distant metastases of primary breast cancer. Oncologist. 2011;16(8):1111-9. doi: 10.1634/theoncologist.2011-0089. Epub 2011 Jul 17. PMID 21765193
• Dashevsky BZ, Goldman DA, Parsons M, Gonen M, Corben AD, Jochelson MS, Hudis CA, Morrow M, Ulaner GA. Appearance of untreated bone metastases from breast cancer on FDG PET/CT: importance of histologic subtype. Eur J Nucl Med Mol Imaging. 2015 Oct;42(11):1666-1673. doi: 10.1007/s00259-015-3080-z. Epub 2015 May 14. PMID 25971426

Идентификаторы

NCT: NCT07285993 · STUDY-25-00364 · PRMC-25-041

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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