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

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ClinicalTrials.gov Identifier: NCT05931302
Recruitment Status : Recruiting
First Posted : July 5, 2023
Last Update Posted : April 1, 2024
Sponsor:
Collaborators:
Institut Curie
Centre Antoine Lacassagne
Information provided by (Responsible Party):
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Lobular Breast Carcinoma Diagnostic Test: 68Ga-FAPI-46 PET scan Not Applicable

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
Actual Study Start Date : November 16, 2023
Estimated Primary Completion Date : April 2026
Estimated Study Completion Date : April 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: 68Ga-FAPI-46 PET scan + 18-FDG PET scan Diagnostic Test: 68Ga-FAPI-46 PET scan

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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05931302


Contacts
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Contact: Florent Hugonnet, MD 07 97 98 96 59 ext +37 florent.hugonnet@chpg.mc
Contact: Magali Cesana 04 83 77 20 60 ext +33 magali.cesana@ch-toulon.fr

Locations
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Monaco
Centre Hospitalier Princesse Grace Recruiting
Monaco, Monaco, 98000
Contact: Florent Hugonnet, MD    07 97 98 96 59 ext +37    florent.hugonnet@chpg.mc   
Sponsors and Collaborators
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Institut Curie
Centre Antoine Lacassagne
Investigators
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Study Director: Florent Hugonnet, MD Centre Hospitalier Princesse Grace
More Information
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Responsible Party: Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
ClinicalTrials.gov Identifier: NCT05931302    
Other Study ID Numbers: 2023-CHITS-006
First Posted: July 5, 2023    Key Record Dates
Last Update Posted: April 1, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer:
68Ga-FAPI-46
18F-FDG PET
FAPα
staging
Additional relevant MeSH terms:
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Carcinoma
Breast Neoplasms
Carcinoma, Lobular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
 Breast Diseases
Skin Diseases
Adenocarcinoma
Neoplasms, Ductal, Lobular, and Medullary
FAPI-46
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action