Name/Description of Trial: GALILEE: Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT / NCT05931302

Summary: Lobular breast cancer staging with 18F-fluorodeoxyglucose positron emission (18F-FDG PET) is not always optimal due to the sometimes poor accumulation of 18F-FDG (glucose uptake) in lobular tumors. 68Ga-FAPI-46 is a new radiotracer for the detection of Fibroblast Activation Protein (FAP) in cancer patients. This study will compare 68Ga-FAPI-46 and 18F-FDG Pet scans in the primary tumor and possible metastases.

Eligible patients: Patients with a minimum of a Stage 2 histological diagnosis of lobular carcinoma of the breast based on a breast biopsy, who have not yet had any treatment and who have not had an FDG Pet Scan within 21 days. Participants with lobular breast carcinoma will then undergo both 18F-FDG and 68Ga-FAPI-46 PET scans. The trial will include approximately 40 patients.

Why is this study beneficial/important?
The primary objective of the study is to compare the sensitivity of 68Ga-FAPI-46 with the sensitivity of 18F-FDG PET in the detection of lobular breast carcinoma lesions. The hypothesis is that through better sensitivity and specificity, 68Ga-FAPI-46 PET could provide a more accurate staging of lobular breast cancer than 18F-FDG PET. These results will be compared with histological data collected before or during surgery and clinical follow-up.

Background: Preliminary results of Lobular Breast Cancer staging with FAPI compounds are encouraging. These results deserve to be confirmed in a well-conducted prospective study. Improved staging and or detection of disease/disease recurrence could result in improved treatment decisions. This study received financial support from Pink Ribbon Monaco, Gemluc (Companies from Monaco fighting Cancer) and Centre Hospitalier Princesse Grace.

Clinical Trial Location(s):
Centre Hospitalier Princesse Grace, Monaco, 98000

Time Commitment /Geographic or Citizenship limitations: No citizenship limitation but participants must understand French and must be seen in Monaco and clinical data will be collected for one year. (The agreement form is in French)

Principal Investigator: Florent Hugonnet, MD, Centre Hospitalier Princesse Grace, Monaco

Trial Contacts:
Florent Hugonnet M.D. email: florent.hugonnet@chpg.mc Ph: + 377 97 98 96 59
Magali Cesana: email: magali.cesana@ch-toulon.fr Ph:  +33 04.83.77.20.60

More information:
https://classic.clinicaltrials.gov/ct2/show/NCT05931302

The Lobular Breast Cancer Alliance (LBCA) shares information about ongoing clinical trials for lobular breast cancer. LBCA does not sponsor or run the clinical trials, and the scientific validity and safety of the trials is the responsibility of the trial investigators. Learn more by directly contacting the clinical trial coordinators listed.

Patients should always discuss their participation in any clinical trial directly with their doctor. Questions to Ask your Doctor may help. Learn more about participating in clinical trials.  Learn about other lobular breast cancer clinical trials and studies.