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| ID | Type | Description | Link |
|---|---|---|---|
| PRMC-25-041 | Other Identifier | Icahn School of Medicine at Mount Sinai |
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| Name | Class |
|---|---|
| The Society of Nuclear Medicine and Molecular Imaging | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 18F-FAPI-74 PET/CT and 18F-FDG PET/CT | Experimental | Study participants will undergo both standard-of-care whole body 18F-FDG PET/CT scan and investigational whole-body scan 18F-FAPI-74 PET/CT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 18F-FAPI-74 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of lesions detected by 18F-FAPI-74 PET/CT | 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. | End of study, at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of lesions detected by 18F-FDG PET/CT but not by 18F-FAPI-74 PET/CT | 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. | End of study, at 1 month |
| Proportion of concordant lesions detected by both 18F-FAPI-74 PET/CT and 18F-FDG PET/CT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ilda Bander | Contact | (212) 241-0763 | Ilda.Bander@mountsinai.org | |
| Rashmi Unawane | Contact | (212) 824-2385 | rashmi.unawane@mssm.edu |
| Name | Affiliation | Role |
|---|---|---|
| Randy Yeh, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28877238 | Background | 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. | |
| 31912902 | Background |
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The completed dataset is the sole property of the Sponsor-Investigator's institution and should not be exported to third parties, except for authorized representatives of appropriate Health/Regulatory Authorities, without permission from the Sponsor-investigator and their institution.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D019788 | Fluorodeoxyglucose F18 |
| ID | Term |
|---|---|
| D003847 | Deoxyglucose |
| D003837 | Deoxy Sugars |
| D002241 | Carbohydrates |
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| 18F-FDG | Drug | 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. |
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| PET/CT | Procedure | 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. |
|
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). |
| End of study, at 1 month |
| Tumor detection rate | Tumor detection rate, defined as the proportion (%) of patients with >1 lesion on 18F-FAPI-74 PET/CT compared to 18F-FDG PET/CT | 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 | 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 | End of study, at 1 month |
| Tumor-to-background ratio (TBR) | 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. | End of study, at 1 month |
| Number of participants with change in therapeutic management decisions | 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. | End of study, at 1 month |
| Change in disease status assessment | 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. | End of study, at 1 month |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |