Comparing two PET scans for staging lobular breast cancer
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT
NA · Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer · NCT05931302
This study is testing which of two different PET scans works better for accurately staging lobular breast cancer in patients who have been diagnosed with it.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer (other) |
| Locations | 1 site (Monaco) |
| Trial ID | NCT05931302 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two different PET scans, 68Ga-FAPI-46 and 18F-FDG, in accurately staging lobular breast carcinoma. Participants diagnosed with lobular breast cancer will undergo both types of PET scans, and the results will be evaluated against histological data obtained from biopsies or surgeries. The primary goal is to determine which PET scan provides better sensitivity and specificity in detecting cancer lesions. Secondary objectives include a comparative analysis of tumor uptake and radiomic studies of both PET scans over a 12-month follow-up period.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histological diagnosis of lobular breast carcinoma who have not yet received any treatment.
Not a fit: Patients with contraindications for PET scans, such as severe claustrophobia or those who have started hormone therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate staging of lobular breast cancer, improving treatment planning and patient outcomes.
How similar studies have performed: While the use of 68Ga-FAPI-46 is a novel approach, previous studies have shown promise in improving cancer imaging techniques.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Monaco
- Centre Hospitalier Princesse Grace — Monaco, Monaco (RECRUITING)
Study contacts
- Study coordinator: Florent Hugonnet, MD
- Email: florent.hugonnet@chpg.mc
- Phone: 07 97 98 96 59
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lobular Breast Carcinoma, 68Ga-FAPI-46, 18F-FDG PET, FAPα, staging