NCT05931302

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Nov 2023Nov 2026

First Submitted

Initial submission to the registry

June 16, 2023

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

November 16, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

June 16, 2023

Last Update Submit

April 10, 2026

Conditions

Lobular Breast Carcinoma

Keywords

68Ga-FAPI-4618F-FDG PETFAPαstaging

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 12 months

Secondary Outcomes (9)

  • SUVmaxFAPI and SUVmaxFDG for each target (Standardized Uptake Value)

    Up to 21 days

  • SUVmaxFAPI/reference and SUVmaxFDG/reference activity ratios

    Up to 21 days

  • MTVFAPI and MTVFDG (Metabolic Tumor Volume)

    Up to 21 days

  • Number of discrepancies between FAPI and FDG PET scans

    Up to 21 days

  • Correlation between PET scan and FAPα labeling

    Up to 12 months

  • +4 more secondary outcomes

Study Arms (1)

68Ga-FAPI-46 PET scan + 18-FDG PET scan

EXPERIMENTAL
Diagnostic Test: 68Ga-FAPI-46 PET scan

Interventions

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.

68Ga-FAPI-46 PET scan + 18-FDG PET scan

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • PET scan contraindications: severe claustrophobia, unbalanced diabetes during 18F-FDG PET scans (fasting capillary blood sugar ≥ 11 mmol)
  • Hormone therapy started
  • F-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

MeSH Terms

Conditions

Carcinoma, Lobular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Ductal, Lobular, and MedullaryBreast NeoplasmsNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Florent Hugonnet, MD

    Centre Hospitalier Princesse Grace

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2023

First Posted

July 5, 2023

Study Start

November 16, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

MO(1)