68Ga-FAPI-46 PET/CT for Predicting Histological Response in Triple-negative Breast Cancer (FAP-IT)

Sponsor
Institut Curie
Study ID
NCT06349512
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 68Ga-FAPI-46 PET/CT imaging — PROCEDURE
    The 68Ga-FAPI-46 PET/CT scan will be performed for each patient pre-therapy and on the same machine as the 18F-FDG PET/CT scan and within 14 days before the start of treatment.

Study Details

Prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68Ga-FAPI-46 PET/CT imaging in patients with early-stage high-risk TNBC.

Key Dates

First listed
Apr 5, 2024
Start date
Oct 14, 2024
Status verified
Dec 2025
Primary completion
Nov 30, 2032
Completion
Nov 30, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Triple Negative Breast Cancer
    Patients with early-stage high-risk Triple Negative Breast Cancer

Primary Outcome Measure

Area under the ROC curve [ Time Frame: 6 months ]

Central Contacts

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