Lobular Breast CarcinomaGALILEENCT05931302
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
A study testing 68Ga-FAPI-46 PET scan in people with Lobular Breast Carcinoma, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in Monaco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lobular Breast Carcinoma
- What is being tested?
- 68Ga-FAPI-46 PET scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteMonaco
- Study dates
- 16 Nov 2023to Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lobular Breast Carcinoma
- Being tested
- 68Ga-FAPI-46 PET scan
- Keywords
- 68Ga-FAPI-46, 18F-FDG PET, FAPα, staging
- Medical subject headings
- Carcinoma, Lobular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
68Ga-FAPI-46 PET scanDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 68Ga-FAPI-46 PET scan + 18-FDG PET scan | Experimental | Not described Receives: Diagnostic Test: 68Ga-FAPI-46 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Secondary outcomes (9)
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
Measured: 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.
Measured: Up to 21 days
MTVFAPI and MTVFDG (Metabolic Tumor Volume)
Comparison of MTVFAPI and MTVFDG in the primary tumor and possible metastases
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 12 months
Specificity comparison
Specificity of 68Ga-FAPI-46 PET scan will be compared to 18F-FDG PET scan specificity
Measured: 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
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start16 Nov 2023
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobular Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
- Sponsor type
- University, hospital or other
- Collaborators
- Institut Curie, Centre Antoine Lacassagne
- Responsible party
- Sponsor
- Investigators
- Florent Hugonnet, MD, Study director, Centre Hospitalier Princesse Grace
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05931302
- Sponsor's protocol ID
- 2023-CHITS-006
- Acronym
- GALILEE
- Status last verified
- Jul 2026
- First submitted
- 16 Jun 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
- ClinicalTrials.gov ID
- NCT05931302
- Acronym / sponsor ID
- GALILEE / 2023-CHITS-006
- Conditions
- Lobular Breast Carcinoma
- Keywords
- 68Ga-FAPI-46, 18F-FDG PET, FAPα, staging
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal de Toulon La Seyne sur MerUniversity, hospital or other
- Collaborators
- Institut Curie, Centre Antoine Lacassagne
- Study start
- 16 Nov 2023 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 5 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 68Ga-FAPI-46 PET scan + 18-FDG PET scan | Experimental | Diagnostic Test: 68Ga-FAPI-46 PET scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 68Ga-FAPI-46 PET scan68Ga-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. | Diagnostic test | 68Ga-FAPI-46 PET scan + 18-FDG PET scan |
Primary outcome
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
9 secondary outcomes
SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)
Time frame: Up to 21 days
SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios
Time frame: Up to 21 days
MTVFAPI and MTVFDG (Metabolic Tumor Volume)
Time frame: Up to 21 days
Number of discrepancies between FAPI and FDG PET scans
Time frame: Up to 21 days
Correlation between PET scan and FAPα labeling
Time frame: Up to 12 months
Correlation between PET scan and breast histology
Time frame: Up to 12 months
Specificity comparison
Time frame: 12 months
Correlation between tumor lesion radiomics and histological characteristics
Time frame: 12 months
Molecular biology analysis of tumor samples
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent Hugonnet, MD study director
Centre Hospitalier Princesse Grace
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 68Ga-FAPI-46 PET scan in people with Lobular Breast Carcinoma, run by Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer at 1 site in Monaco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Monaco. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.