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NCT Number: NCT05931302

Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT

Lobular Breast cancer staging with 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is not optimal due to the poor accumulation of 18F-FDG in the tumour. Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET.

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Key information

Conditions

Lobular Breast Carcinoma Adenocarcinoma Breast Diseases Breast Neoplasms Carcinoma Carcinoma, Lobular Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Princesse Grace

Monaco, 98000

About this study

Research hypothesis : Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET. Participants with lobular breast carcinoma will then undergo 18F-FDG and 68Ga-FAPI-46 PET scan.

Primary objective of the study is to compare the sensitivity of 68Ga-FAPI-46 with the sensitivity of 18F-FDG in the detection of lobular breast carcinoma lesions, measured by positron emission tomography (PET). These results will be compared with the histological data collected before or during surgery (conventional histological data and immunohistochemical labeling of FAPα on the sample obtained), clinical follow-up and any results of additional examinations carried out within the usual clinical follow-up of the patients.

Comparison of primary tumor and metastases uptake of 68Ga-FAPI-46 with the uptake of 18F-FDG, radiomic study of 68Ga-FAPI-46 PET and comparative radiomic study of 68Ga-FAPI-46 PET and 18F-FDG PET and comparison of the specificity of 68Ga-FAPI-46 with the specificity of 18F-FDG after a 12-month follow-up will also be performed as secondary objectives.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age greater than or equal to 18 years
  • ECOG from 0 to 2
  • Histological diagnosis of Lobular Carcinoma of the breast based on a breast biopsy
  • Patient naïve to any treatment for lobular breast carcinoma
  • Women of childbearing age should have an adequate method of contraception
  • Patient having voluntarily accepted to participate in the study and signed the informed consent
  • Minimum tumor stage IIA
  • Sufficient histological material in the biopsy or the surgical specimen, if the biopsy is insufficient

Exclusion criteria

  • PET scan contraindications: severe claustrophobia, unbalanced diabetes during 18F-FDG PET scans (fasting capillary blood sugar ≥ 11 mmol)
  • Hormone therapy started
  • 18F-FDG PET scan > 21 days
  • Pregnant women, parturients and nursing mothers
  • Persons deprived of liberty by a judicial or administrative decision
  • Persons admitted to a health or social establishment for purposes other than research
  • Adults who are the subject of a legal protection measure or who are unable to express their consent

Treatment and study plan

68Ga-FAPI-46 PET scan

Diagnostic Test

68Ga-FAPI-46 is a radiotracer for the detection of Fibroblast Activation Protein (FAP) in cancer patients.

68Ga-FAPI-46 will be administered intravenously at a dose of 2MBq/kg. Patients will be scanned 60 minutes after administration of 68Ga-FAPI-46.

Primary outcomes

  1. Number of positive tumor lesions, i.e. confirmed by additional imaging, histopathology/biopsy or response to treatment (on imaging or clinical assessment)

    Time frame: Up to 12 months

    Number of positive tumor lesions of 68Ga-FAPI-46 PET scan in comparison with 18F-FDG PET scan

Secondary outcomes

  1. SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)

    Time frame: Up to 21 days

    Comparison of 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases

  2. SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios

    Time frame: Up to 21 days

    Comparison of (SUVmaxFAPI/reference) and (SUVmaxFDG/reference) activity ratios. For the primary tumour, the reference activity will be measured in either the periphery of the lesion or on a homologous healthy tissue. For a vertebral metastasis, the reference activity will be measured in an adjacent healthy vertebra.

  3. MTVFAPI and MTVFDG (Metabolic Tumor Volume)

    Time frame: Up to 21 days

    Comparison of MTVFAPI and MTVFDG in the primary tumor and possible metastases

  4. Number of discrepancies between FAPI and FDG PET scans

    Time frame: Up to 21 days

    Discrepancies (discordant pairs) between 68Ga-FAPI-46 PET scan and 18F-FDG PET scan will be analyzed

  5. Correlation between PET scan and FAPα labeling

    Time frame: Up to 12 months

    Correlation between PET scan results and measurement of the FAPα labeling density on the biopsy

  6. Correlation between PET scan and breast histology

    Time frame: Up to 12 months

    Correlation between PET scans results and standard measurements in breast histology: OR (estrogen receptors), PR (progesterone receptors), HER2 (Human Epidermal Growth Factor Receptor-2), Ki-67 antigen, Ecadherin

  7. Specificity comparison

    Time frame: 12 months

    Specificity of 68Ga-FAPI-46 PET scan will be compared to 18F-FDG PET scan specificity

  8. Correlation between tumor lesion radiomics and histological characteristics

    Time frame: 12 months

    1st order characteristics reflecting the distribution of gray levels determined by radiomics study of 68Ga-FAPI PET scan and 18F-FDG PET scan

  9. Molecular biology analysis of tumor samples

    Time frame: 12 months

    Bioinformatics analysis of tumor sample celullar composition in terms of fibroblasts expressing FAP protein after total RNA extraction.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Other

Collaborators

  • Centre Antoine Lacassagne
  • Institut Curie

Registry information

Acronym: GALILEE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 5, 2023
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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