Assessement of Potential Interest of [68Ga]Ga-PentixaFor PET/CT in Metastatic Triple Negative Breast Cancer Patients

Sponsor
Institut Cancerologie de l'Ouest
Study ID
NCT06962163
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • [68Ga]Ga-PentixaFor PET/CT — DIAGNOSTIC_TEST
    \[68Ga\]Ga-PentixaFor PET-CT is performed after patient inclusion. The patient is treated as per standard of care until disease progression. Then another \[68Ga\]Ga-PentixaFor PET-CT is performed.

Study Details

Triple-negative breast cancer (TNBC) is a particularly aggressive type of breast cancer that is difficult to treat. Unlike other forms of breast cancer, TNBC tends to relapse earlier and spread more quickly to other parts of the body. Unfortunately, patients with TNBC have a lower survival rate, often less than five years after diagnosis. This highlights the urgent need for better treatments for TNBC. One of the main challenges in treating TNBC is that it lacks certain receptors that other breast cancers have. These receptors are usually targeted by specific therapies, making TNBC harder to treat with targeted approaches. Currently, a type of imaging called \[18F\]FDG PET/CT is the most accurate method for detecting breast cancer and its spread. However, with the rise of personalized medicine, there is a growing interest in molecular targeted approaches. These methods aim to provide highly specific diagnostics and treatments based on the unique characteristics of each patient's cancer. One promising target for these new approaches is a receptor called CXCR4. CXCR4 is found on the surface of many cells and is involved in various processes in the body. It is often overexpressed in different types of cancer, including breast cancer. Research has shown that CXCR4 levels are higher in metastatic sites (where cancer has spread) compared to primary tumors. CXCR4 is not only present in cancer cells but also in immune cells within the tumor environment. In invasive breast cancer, CXCR4 plays a crucial role in tumor migration, invasiveness, metastasis, and proliferation. A clinical study evaluated 18 breast cancer patients using a new imaging method called \[68Ga\]Ga-PentixaFor PET/CT or PET/MR. They found that this method showed higher uptake in breast cancer cases with poorer prognosis compared to the traditional \[18F\]FDG PET/CT. Higher CXCR4 expression is particularly seen in TNBC compared to other breast cancer subtypes. The goal of the study is to assess how \[68Ga\]Ga-PentixaFor is distributed in the body using PET/CT imaging. This will help demonstrate the potential of CXCR4 as a promising target for new treatments. If successful, \[68Ga\]Ga-PentixaFor PET/CT could become a valuable tool for identifying patients who might benefit from treatments using \[177Lu\]/\[90Y\] PentixaTher.

Key Dates

First listed
May 8, 2025
Start date
Dec 5, 2025
Status verified
Dec 2025
Primary completion
Jun 30, 2027
Completion
Jun 30, 2030

Study Design

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

Arms

  • Experimental: [68Ga]Ga-PentixaFor
    2 \[68Ga\]Ga-PentixaFor PET-CT are performed after patient inclusion and at disease progression.

Primary Outcome Measure

To assess the concordance for tumour lesion detection with [68Ga]Ga-PentixaFor PET/CT and [18F]FDG PET/CT based on a lesion-by-lesion basis analysis performed at patient inclusion [ Time Frame: 1 day ]

Central Contacts

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