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Not yet recruiting NCT07285993

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

Phase II Interventional Breast Cancer Metastatic Invasive Lobular Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 18F-FAPI-74, 18F-FDG, PET/CT.
Who it may be relevant to
Registry conditions: Breast Cancer, Metastatic Invasive Lobular Breast Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug 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.
  • Drug 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.
  • Procedure 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.

Primary outcome measures

  • Proportion of lesions detected by 18F-FAPI-74 PET/CT [Time frame: End of study, at 1 month]
Secondary outcome measures (7)
  • Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT [Time frame: End of study, at 1 month]
  • Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT [Time frame: End of study, at 1 month]
  • Tumor detection rate [Time frame: 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 [Time frame: End of study, at 1 month]
  • Tumor-to-background ratio (TBR) [Time frame: End of study, at 1 month]
  • Number of participants with change in therapeutic management decisions [Time frame: End of study, at 1 month]
  • Change in disease status assessment [Time frame: End of study, at 1 month]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Icahn School of Medicine at Mount Sinai — New York

Publications

  • 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

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗