Lobular CarcinomaFAPI-CLNCT07313033
[68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL).
A study testing [68]GA-FAPI-46 PET scan in people with Lobular Carcinoma and Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Invasive squamous cell carcinoma (ISCC) represents 5 to 15% of breast cancers. Despite the rarity of this pathology, the number of patients with Invasive squamous cell carcinoma treated at HCL is significant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Lobular Carcinoma, Breast Cancer
- What is being tested?
- [68]GA-FAPI-46 PET scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2026to 30 Aug 2027
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient (≥18 years old),
- Beneficiary or entitled to a social security system;
- Patient having agreed to participate in the study and signed written informed consent;
- 18F-FDG PET/CT performed as part of the assessment of extension of an infiltrating lobular carcinoma, the result of which is negative or doubtful on at least one lesion.
Who cannot join
- Pregnant, parturient or breastfeeding women. A pregnancy test before inclusion will be carried out for women of childbearing age.
- Persons deprived of liberty by a judicial or administrative decision
- People receiving psychiatric care
- People admitted to a health or social establishment for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
- Subjects participating in another interventional research including an exclusion period still ongoing at inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
Lyon sud Hospital center - Hospices Civils de Lyon
Lyon
Nicolas Jacquet-Francillon, +33 4 72 35 69 99, nicolas.jacquet-francillon@chu-lyon.fr
About this study
Official title: [68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL)
Invasive squamous cell carcinoma (ISCC) represents 5 to 15% of breast cancers. Despite the rarity of this pathology, the number of patients with Invasive squamous cell carcinoma treated at HCL is significant.
Patients at risk of metastasis are usually referred to the HCL Nuclear Medicine departments to perform positron emission tomography - computed tomography (PET/CT) with [18]F-FDG as an extension assessment. The investigators know that [18]F-FDG PET/CT has limited diagnostic performance for assessing the extent of breast cancer with a sensitivity of 66-96% for all histologies combined. For the ISCC, these performances are even lower with average Standard Uptake Value (SUV) values of 3.4 [2.8-3.9] versus 6.6 [4.8-9.7] for the others histological types of breast cancer. False negatives in [18]F-FDG PET/CT are due to an insufficient osteoblastic and immune response in the tumor stroma. Avril \& al. showed 65.2% false negatives with [18]F-FDG PET/CT for ISCC. This is why the search for new imaging techniques in this indication is particularly relevant.
Read more
Targeting fibroblast activation protein (FAP), a type II membrane glycoprotein belonging to the dipeptidyl peptidase-4 family, is a promising strategy for imaging tumor stroma, particularly in epithelial carcinomas .
The investigators would like to compare the [18]F-FDG PET/CT technique currently used to this new emerging modality.
The investigators hypothesize superior diagnostic performance of [68]Ga-FAPI PET/CT compared to [18]F-FDG PET/CT for the assessment of ISCC extension, with a gold standard histological.
The investigators translate this into the hypothesis of finding 30% of positive FAPI PET when the [18F]FDG PET/CT is negative or doubtful.
The advantage of this project and this new imaging modality is to not undertreat patients wrongly classified as non-metastatic. The investigators therefore wish to offer [68]Ga-FAPI PET/CT to patients with negative [18]F-FDG PET/CT.
The FAPICL project constitutes a seed project before a larger structuring study.
- Conditions
- Lobular Carcinoma, Breast Cancer
- Being tested
- [68]GA-FAPI-46 PET scan
- Keywords
- lobular carcinoma, medical imaging at [68]GA-FAPI-46 PET scan, oncology, gynecology
- Medical subject headings
- Carcinoma, Lobular, Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[68]GA-FAPI-46 PET scanOther
Realization of a [68]GA-FAPI-46 PET scan to detect at least one [68]GA-FAPI positive lesion (confirmed by histology)
| Study group | Role | What they receive |
|---|---|---|
| Control | Experimental | Adult patients with infiltrating lobular carcinomas. Patients must have had a negative or doubtful 18F-FDG PET/CT scan as part of their routine care pathway Receives: Other: [68]GA-FAPI-46 PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative
Measured: 6 weeks
Secondary outcomes (4)
Average number per patient of lesions demonstrated in [68]Ga-FAPI, not seen in [18F]-FDG
This criteria will be collected when the imaging is read by a nuclear physician.
Measured: 6 weeks
Number of lesions positive on histology, among the lesions visualized on PET/CT with [68]Ga-FAPI (and in the case of negative histology, identify the differential diagnoses)
This criteria will be collected at the time of publication of the histological report of the suspicious lesion detected.
Measured: 6 weeks
Evaluate the Positive Predictive Value of [68]Ga-FAPI PET/CT at the patient level, in patients negative on [18]F-FDG PET/CT
This criterion will be collected at the time of publication of the histological report of the suspicious lesion detected.
Measured: 6 weeks
Analyze the semi-quantitative values of the PET signal by describing the [68Ga]-FAPI lesional SUVs, compared to the vascular and hepatic background
SUVmax bw lesion, SUVmax liver, SUVmax aorta will be collected at the time of reading the imaging by a nuclear physician, for each suspicious lesion
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2025
- Study start30 Mar 2026 (estimated)
- Primary completion30 May 2027 (estimated)
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lobular CarcinomaStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Model description
- Patients will carry out 2 examinations \[18F\]-FDG and \[68\]GA-FAPI-46 PET scan and the gold standard will be histology
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07313033
- Sponsor's protocol ID
- 69HCL23_1133
- Other IDs
- 2025-524897-40-00, 2025
- Acronym
- FAPI-CL
- Status last verified
- Dec 2025
- First submitted
- 17 Dec 2025
- Last updated
- 16 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- [68]GA-FAPI-46 PET/CT for the Diagnosis of Metastatic Lesions in Patients With Lobular Breast Cancer (ICL)
- ClinicalTrials.gov ID
- NCT07313033
- Acronym / sponsor ID
- FAPI-CL / 69HCL23_1133
- Conditions
- Lobular Carcinoma, Breast Cancer
- Keywords
- lobular carcinoma, medical imaging at [68]GA-FAPI-46 PET scan, oncology, gynecology
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- 30 May 2027 (estimated)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 31 Dec 2025 (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.
Invasive squamous cell carcinoma (ISCC) represents 5 to 15% of breast cancers. Despite the rarity of this pathology, the number of patients with Invasive squamous cell carcinoma treated at HCL is significant.
Patients at risk of metastasis are usually referred to the HCL Nuclear Medicine departments to perform positron emission tomography - computed tomography (PET/CT) with [18]F-FDG as an extension assessment. The investigators know that [18]F-FDG PET/CT has limited diagnostic performance for assessing the extent of breast cancer with a sensitivity of 66-96% for all histologies combined. For the ISCC, these performances are even lower with average Standard Uptake Value (SUV) values of 3.4 [2.8-3.9] versus 6.6 [4.8-9.7] for the others histological types of breast cancer. False negatives in [18]F-FDG PET/CT are due to an insufficient osteoblastic and immune response in the tumor stroma. Avril \& al. showed 65.2% false negatives with [18]F-FDG PET/CT for ISCC. This is why the search for new imaging techniques in this indication is particularly relevant.
Targeting fibroblast activation protein (FAP), a type II membrane glycoprotein belonging to the dipeptidyl peptidase-4 family, is a promising strategy for imaging tumor stroma, particularly in epithelial carcinomas .
The investigators would like to compare the [18]F-FDG PET/CT technique currently used to this new emerging modality.
The investigators hypothesize superior diagnostic performance of [68]Ga-FAPI PET/CT compared to [18]F-FDG PET/CT for the assessment of ISCC extension, with a gold standard histological.
The investigators translate this into the hypothesis of finding 30% of positive FAPI PET when the [18F]FDG PET/CT is negative or doubtful.
The advantage of this project and this new imaging modality is to not undertreat patients wrongly classified as non-metastatic. The investigators therefore wish to offer [68]Ga-FAPI PET/CT to patients with negative [18]F-FDG PET/CT.
The FAPICL project constitutes a seed project before a larger structuring study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will carry out 2 examinations [18F]-FDG and [68]GA-FAPI-46 PET scan and the gold standard will be histology
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Other: [68]GA-FAPI-46 PET scanAdult patients with infiltrating lobular carcinomas. Patients must have had a negative or doubtful 18F-FDG PET/CT scan as part of their routine care pathway |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patient (≥18 years old),
- Beneficiary or entitled to a social security system;
- Patient having agreed to participate in the study and signed written informed consent;
- 18F-FDG PET/CT performed as part of the assessment of extension of an infiltrating lobular carcinoma, the result of which is negative or doubtful on at least one lesion.
Key exclusion criteria (6 listed)
- Pregnant, parturient or breastfeeding women. A pregnancy test before inclusion will be carried out for women of childbearing age.
- Persons deprived of liberty by a judicial or administrative decision
- People receiving psychiatric care
- People admitted to a health or social establishment for purposes other than research
- Adults subject to a legal protection measure (guardianship, curatorship)
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 |
|---|---|---|
| [68]GA-FAPI-46 PET scanRealization of a [68]GA-FAPI-46 PET scan to detect at least one [68]GA-FAPI positive lesion (confirmed by histology) | Other | Control |
Primary outcome
Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative
Time frame: 6 weeks
4 secondary outcomes
Average number per patient of lesions demonstrated in [68]Ga-FAPI, not seen in [18F]-FDG
Time frame: 6 weeks
Number of lesions positive on histology, among the lesions visualized on PET/CT with [68]Ga-FAPI (and in the case of negative histology, identify the differential diagnoses)
Time frame: 6 weeks
Evaluate the Positive Predictive Value of [68]Ga-FAPI PET/CT at the patient level, in patients negative on [18]F-FDG PET/CT
Time frame: 6 weeks
Analyze the semi-quantitative values of the PET signal by describing the [68Ga]-FAPI lesional SUVs, compared to the vascular and hepatic background
Time frame: 6 weeks
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 16 Jan 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [68]GA-FAPI-46 PET scan in people with Lobular Carcinoma and Breast Cancer, run by Hospices Civils de Lyon at 1 site in France.
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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 16 Jan 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 France. 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?
Contact Nicolas Jacquet-Francillon (+33 4 72 35 69 99, nicolas.jacquet-francillon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients for whom at least one secondary lesion is demonstrated in [68]Ga-FAPI and confirmed by histology, when [18]F-FDG PET/CT is negative (time frame: 6 weeks). 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 16 Jan 2026.