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Study on Detecting Hidden Invasive Breast Cancer in Patients with Ductal Carcinoma In Situ Using [68Ga]FAPI-46 and Gadobutrol

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying breast cancer, specifically a type called ductal carcinoma in situ (DCIS). The study will use a special imaging technique called FAPI-PET/MRI to help detect hidden invasive cancer in patients who have been diagnosed with DCIS. The imaging involves two substances: [68Ga]FAPI-46, which is given as an infusion, and Gadovist®, a solution for injection. These substances help create clearer images of the breast tissue during the scan.

The purpose of the study is to see if this imaging method can effectively find invasive cancer that might not be visible with other techniques. Participants will receive the imaging substances through an intravenous injection, which means they are given directly into a vein. The study will involve a series of imaging sessions where the effectiveness of the FAPI-PET/MRI in detecting cancer will be evaluated. The trial aims to improve the accuracy of breast cancer diagnosis and potentially reduce the need for additional biopsies.

Throughout the study, the safety and any side effects of using [68Ga]FAPI-46 will be closely monitored. The trial will also compare the new imaging method with traditional MRI to see which is more effective in identifying cancer. This research hopes to provide better tools for doctors to diagnose and treat breast cancer, ultimately improving patient care and outcomes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying a diagnosis of ductal carcinoma in situ (DCIS) with a suspected extent greater than 4 cm, as seen in mammography, MRI, or ultrasound.
A negative pregnancy test is required for women of childbearing potential. Consent forms are signed, and contraception agreements are confirmed for participants of reproductive potential.
Step 2
Imaging procedure
The imaging procedure involves a PET/MRI scan using [68Ga]FAPI-46 and Gadovist® as contrast agents. [68Ga]FAPI-46 is administered via intravenous injection as a solution for infusion.
The scan aims to detect any hidden invasive cancer within the diagnosed DCIS. The procedure evaluates the feasibility of using this imaging method for accurate detection.
Step 3
Follow-up assessments
Follow-up assessments are conducted to evaluate the sensitivity and specificity of the imaging results. This involves analyzing the PET/MRI visual assessment scores.
Additional biopsies may be performed if the imaging results suggest further investigation is needed.
Step 4
Final evaluation
The final evaluation includes a comprehensive review of all imaging and biopsy results. The primary focus is on the sensitivity and specificity of the imaging techniques used.
The study aims to determine the optimal threshold for detecting invasive cancer and assess any adverse events following the application of [68Ga]Ga-FAPI-46.

Who can join the trial?

6 criteria

The patient must have been newly diagnosed with DCIS (Ductal Carcinoma In Situ), which is a type of breast cancer, and the area affected should be suspected to be larger than 4 cm based on mammography, MRI, or ultrasound.
The patient should have a planned surgery to remove the DCIS, which could be either breast-conserving surgery or a mastectomy, as recommended by guidelines.
The patient must be 18 years of age or older.
The patient must provide written informed consent, which means they agree to participate in the study after being informed about it.
For women who can have children, they must have a confirmed menstrual period (if applicable) and a negative result on a highly sensitive urine or blood pregnancy test.
Women who can have children and men with partners who can have children must agree to use highly effective birth control methods when sexually active. This requirement is in place from the time they sign the consent form until the final visit of the trial.

Who cannot join the trial?

4 criteria

Patients who are not diagnosed with breast cancer or ductal carcinoma in situ (a condition where abnormal cells are found in the lining of a breast duct).
Patients who are not within the specified age range for the study.
Patients who do not meet the gender requirements for the study.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Universitaetsklinikum Essen AöR
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Essen, Germany
Universitaetsklinikum Muenster AöR
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Munster, Germany

Trial locations

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Investigated drugs

[68Ga]Ga-FAPI-46 is a radiotracer used in PET/MRI imaging. It helps in detecting hidden invasive cancer in patients who have been diagnosed with ductal carcinoma in situ (DCIS) of the breast. This imaging agent binds to certain proteins that are often found in higher amounts in cancerous tissues, allowing doctors to see areas that might be cancerous during the imaging process.

What is already known about the treatment

[68Ga]Ga-FAPI-46 – This medication is administered through an injection and is used in combination with PET/MRI imaging. It is currently being studied in clinical trials for its ability to detect hidden invasive cancer in patients diagnosed with ductal carcinoma in situ (DCIS) and breast cancer. The main therapeutic indication is to improve the detection of cancerous tissues that are not easily visible with standard imaging techniques. At the molecular level, it works by targeting fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for enhanced imaging contrast. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Breast Cancer
Breast cancer is a disease where cells in the breast grow uncontrollably. It often begins in the ducts or lobules of the breast. As it progresses, it can spread to nearby tissues or other parts of the body. The disease can manifest as a lump in the breast, changes in breast shape, or skin dimpling. It may also cause fluid discharge from the nipple. The progression varies, with some forms growing slowly and others more rapidly.
Ductal Carcinoma In Situ
Ductal carcinoma in situ (DCIS) is a non-invasive breast cancer where abnormal cells are found in the lining of a breast duct. It is considered the earliest form of breast cancer and is confined to the ducts. DCIS does not spread beyond the duct into the surrounding breast tissue. It is often detected through mammograms as it may not cause noticeable symptoms. If left untreated, it can progress to invasive breast cancer. The progression of DCIS is generally slow, but monitoring is essential to prevent advancement.