An interventional study of 68Ga-FAPI-46 PET scan in Lobular Breast Carcinoma, sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer. Active, not recruiting at 1 site in Monaco. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · Not applicable, Interventional, and Diagnostic
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.
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.
69 studies on the registry are indexed under Carcinoma, Lobular; 18 are open to participants now.
This study's enrollment of 40 is below the median of 59 across 49 interventional studies indexed under Carcinoma, Lobular.
Browse Carcinoma, Lobular studies →Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer is the lead sponsor of 78 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
Number of positive tumor lesions of 68Ga-FAPI-46 PET scan in comparison with 18F-FDG PET scan
Time frame: Up to 12 months
SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
Comparison of 68Ga-FAPI-46 and 18F-FDG Standardized Uptake Value in the primary tumor and possible metastases
Time frame: Up to 21 days
SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios
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.
Time frame: Up to 21 days
MTVFAPI and MTVFDG (Metabolic Tumor Volume)
Comparison of MTVFAPI and MTVFDG in the primary tumor and possible metastases
Time frame: Up to 21 days
Number of discrepancies between FAPI and FDG PET scans
Discrepancies (discordant pairs) between 68Ga-FAPI-46 PET scan and 18F-FDG PET scan will be analyzed
Time frame: Up to 21 days
Correlation between PET scan and FAPα labeling
Correlation between PET scan results and measurement of the FAPα labeling density on the biopsy
Time frame: Up to 12 months
Correlation between PET scan and breast histology
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
Time frame: Up to 12 months
Specificity comparison
Specificity of 68Ga-FAPI-46 PET scan will be compared to 18F-FDG PET scan specificity
Time frame: 12 months
Correlation between tumor lesion radiomics and histological characteristics
1st order characteristics reflecting the distribution of gray levels determined by radiomics study of 68Ga-FAPI PET scan and 18F-FDG PET scan
Time frame: 12 months
Molecular biology analysis of tumor samples
Bioinformatics analysis of tumor sample celullar composition in terms of fibroblasts expressing FAP protein after total RNA extraction.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer