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[68]GA-FAPI-46 PET/CT for the diagnosis of metastatic lesions in patients with lobular breast cancer (ICL). FAPICL

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524897-40-00
Enrollment
45
Registered
2026-08-25
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

invasive lobular carcinomas of the breast

Brief summary

Percentage of patients for whom at least one secondary lesion is detected with [68]Ga-FAPI and confirmed by histology, when the [18]F-FDG PET/CT is negative.

Detailed description

Average number per patient of lesions detected with [68]Ga-FAPI, not seen on [18F]-FDG. This criterion will be collected at the time of the imaging review by a nuclear medicine physician., Number of positive lesions in histology, among the lesions visualized in PET/CT with [68]Ga-FAPI (and in case of negative histology, identify the differential diagnoses). This criterion will be collected at the time of publication of the histological report of the detected suspicious lesion., This criterion will be collected and compared at the time of the publication of the histological report of the detected suspicious lesion and between the 2 PET scans., The values of SUVmax lesion, SUVmax liver, SUVmax aorta will be collected at the time of the imaging interpretation by a nuclear medicine physician, for each suspicious lesion., Estimate the number of lesions detected by PET/CT with [68]Ga-FAPI and not detected by PET/CT with [18]F-FES in our study population., Estimate the number of lesions detected on PET/CT with [18]F-FES and not detected on PET/CT with [68]Ga-FAPI in our study population

Interventions

Sponsors

Hospices Civils De Lyon
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Percentage of patients for whom at least one secondary lesion is detected with [68]Ga-FAPI and confirmed by histology, when the [18]F-FDG PET/CT is negative.

Secondary

MeasureTime frame
Average number per patient of lesions detected with [68]Ga-FAPI, not seen on [18F]-FDG. This criterion will be collected at the time of the imaging review by a nuclear medicine physician., Number of positive lesions in histology, among the lesions visualized in PET/CT with [68]Ga-FAPI (and in case of negative histology, identify the differential diagnoses). This criterion will be collected at the time of publication of the histological report of the detected suspicious lesion., This criterion will be collected and compared at the time of the publication of the histological report of the detected suspicious lesion and between the 2 PET scans., The values of SUVmax lesion, SUVmax liver, SUVmax aorta will be collected at the time of the imaging interpretation by a nuclear medicine physician, for each suspicious lesion., Estimate the number of lesions detected by PET/CT with [68]Ga-FAPI and not detected by PET/CT with [18]F-FES in our study population., Estimate the number of lesions det

Outcome results

None listed

Source: EU CTIS · Data processed: Aug 26, 2026