Breast Cancer, Metastatic Invasive Lobular Breast Cancer
Conditions
Keywords
Breast Cancer, Novel F-18 FAPI PET, Metastatic, Invasive, Lobular, 18F-FDG PET/CT
Brief summary
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
DRUG18F-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.
DRUG18F-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.
PROCEDUREPET/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.
Sponsors
Randy Yeh
The Society of Nuclear Medicine and Molecular Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of lesions detected by 18F-FAPI-74 PET/CT | End of study, at 1 month | Proportion of lesions detected by 18F-FAPI-74 PET/CT but not by 18F-FDG PET/CT. All lesions will be mapped across both imaging modalities to determine whether they were detected by FAPI PET/CT but not by FDG PET/CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT | End of study, at 1 month | All lesions will be mapped across both imaging modalities to determine whether they were detected by FDG PET/CT but not by FAPI PET/CT. |
| Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT | End of study, at 1 month | All lesions will be mapped across both imaging modalities to determine whether they were detected by both FAPI PET/CT and FDG PET/CT (i.e., concordant detection). |
| Tumor detection rate | End of study, at 1 month | Tumor detection rate, defined as the proportion (%) of patients with \>1 lesion on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT |
| 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 | End of study, at 1 month | SUVmax of each lesion identified on both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT. Two summary metrics will be derived per patient per modality: Hottest lesion SUVmax: Defined as the highest SUVmax value among all detected lesions per patient per modality. Overall SUVmax: model lesion-level SUVmax values |
| Tumor-to-background ratio (TBR) | End of study, at 1 month | Tumor-to-Background Ratio (TBR) will be defined as the SUVmax of the hottest lesion divided by the SUVmax of two background regions: the liver and the aortic blood pool. |
| Number of participants with change in therapeutic management decisions | End of study, at 1 month | Number of participants with change in therapeutic management decisions following review of 18F-FAPI-74 PET/CT compared to decisions based on 18F-FDG PET/CT alone For each patient, an initial therapeutic management plan will be recorded based on findings from the 18F-FDG PET/CT scan alone. After the subsequent review of the 18F-FAPI-74 PET/CT scan, a revised management plan will be documented, reflecting any changes informed by the additional imaging data. |
| Change in disease status assessment | End of study, at 1 month | Change in disease status assessment (responding, stable, progressing) by treating physicians following review of 18F-FAPI-74 PET/CT compared to assessment based on 18F-FDG PET/CT alone Treating physicians will assign a disease status classification (responding, stable, or progressing) based on available clinical and imaging data from 18F-FDG PET/CT and then after reviewing the 18F-FAPI-74 PET/CT scan. We will summarize the distribution of disease status before and after the FAPI scan, along with the number and percentages of patients whose disease status assessment changed following the FAPI scan, along with the specific nature of those changes. |
Countries
United States
Contacts
CONTACTIlda Bander
CONTACTRashmi Unawane
PRINCIPAL_INVESTIGATORRandy Yeh, MD
Icahn School of Medicine at Mount Sinai
Outcome results
None listed