Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET
NCT ID: NCT07285993
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE2
15 participants
INTERVENTIONAL
2025-12-30
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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18F-FAPI-74 PET/CT and 18F-FDG PET/CT
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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 cannot undergo PET/CT scanning
* Patients with total serum bilirubin or serum creatinine \> 1.5 times the upper limit of normal
18 Years
FEMALE
No
Sponsors
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The Society of Nuclear Medicine and Molecular Imaging
UNKNOWN
Randy Yeh
OTHER
Responsible Party
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Randy Yeh
Associate Professor
Principal Investigators
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Randy Yeh, MD
Role: PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Locations
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Icahn School of Medicine at Mount Sinai
New York, New York, United States
Countries
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Central Contacts
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References
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Other Identifiers
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PRMC-25-041
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY-25-00364
Identifier Type: -
Identifier Source: org_study_id