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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Lobular Breast Carcinoma | Diagnostic Test: 68Ga-FAPI-46 PET scan | Not Applicable |
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 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 |
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. |
- 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
- 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
- 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.
- MTVFAPI and MTVFDG (Metabolic Tumor Volume) [ Time Frame: Up to 21 days ]Comparison of MTVFAPI and MTVFDG in the primary tumor and possible metastases
- 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
- 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
- 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
- Specificity comparison [ Time Frame: 12 months ]Specificity of 68Ga-FAPI-46 PET scan will be compared to 18F-FDG PET scan specificity
- 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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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
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
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 |
Monaco | |
Centre Hospitalier Princesse Grace | Recruiting |
Monaco, Monaco, 98000 | |
Contact: Florent Hugonnet, MD 07 97 98 96 59 ext +37 florent.hugonnet@chpg.mc |
Study Director: | Florent Hugonnet, MD | Centre Hospitalier Princesse Grace |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
68Ga-FAPI-46 18F-FDG PET FAPα staging |
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 |