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Diagnostic Accuracy of [68Ga]FAPI-46 PET/CT for Detecting Metastatic Lesions in Patients with Invasive Lobular Breast Cancer

Verified siteInvestigationalNo placebo

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What is this trial about?

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

The study focuses on invasive lobular carcinoma of the breast, a form of breast cancer that often spreads in a subtle pattern. Participants receive an imaging agent called [68Ga]FAPI-46 through an intravenous injection, which helps a special scanner to highlight cancer‑related areas. The scan is a type of PET/CT that combines a camera detecting radioactive material with a CT picture of the body, and the results are compared with a standard FDG PET/CT scan that uses a different tracer.

The purpose of the study is to determine whether the new [68Ga]FAPI-46 scan can identify additional metastatic lesions when the standard scan does not show clear results. After the initial standard scan, participants undergo the experimental scan, and if any suspicious spots are seen, a small tissue sample may be taken for histology—the process of examining cells under a microscope—to confirm whether the spots are cancer. The imaging reports also note the SUVmax value, a number that reflects how strongly the tracer accumulates in a lesion.

Throughout the study, the imaging results are reviewed by specialists, any needed biopsies are performed, and the findings from both scans are compared to see which method detects more disease spread. The entire process takes place over a short series of visits, and no additional treatment is given beyond the imaging procedures.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After joining the study you sign the consent form and provide basic health information.
The study team records your weight to calculate the medication dose.
Step 2
Baseline 18f-fdg pet/ct scan
A standard pet/ct scan using the tracer 18f-fdg is performed to look for cancer spread.
If this scan shows no lesions or unclear results, you will proceed to the next imaging step.
Step 3
Preparation for 68ga-fapi-46 injection
An intravenous line is placed in a vein.
The dose of 68ga-fapi-46 is calculated as 2 mbq per kilogram of your body weight.
Step 4
Administration of 68ga-fapi-46
The medication, a solution for injection, is given by intravenous injection.
The injection is performed on the same day as the imaging.
Step 5
Uptake period before imaging
After the injection you wait a short period as instructed by the study team to allow the tracer to distribute in the body.
Step 6
68ga-fapi-46 pet/ct scan
A pet/ct scan using the tracer 68ga-fapi-46 is performed to detect metastatic lesions.
The images are captured and stored for later review.
Step 7
Image analysis
A nuclear medicine physician reviews the images, notes the number of lesions, and records values such as suvmax for lesions, liver and aorta.
The findings are compared with the earlier 18f-fdg scan.
Step 8
Biopsy of suspicious lesions
If the scan shows new or uncertain lesions, a tissue sample (biopsy) may be taken to confirm the diagnosis by histology.
The histology report is used to verify whether the lesions are cancerous.
Step 9
Final assessment and study completion
All imaging and histology results are compiled to determine the study outcomes.
You are informed that your participation in the trial is complete.

Who can join the trial?

5 criteria

Adult patient (≥ 18 years old) – you must be at least 18 years of age.
Beneficiary of a social security scheme – you need to be covered by a public health or social security program.
Signed written informed consent – you must agree to take part in the study and sign a consent form.
PET/CT scan with 18F‑FDG performed for staging or restaging – you must have had a combined imaging test (PET/CT) that uses a radioactive sugar called 18F‑FDG to look for cancer spread, done as part of the initial evaluation or follow‑up of an invasive lobular carcinoma of the breast. The scan results must show no clear sign or an uncertain sign of at least one lesion.
Effective contraception for those who could become pregnant – if you are able to have children, you must use a highly reliable birth‑control method during the study, and a blood pregnancy test will be done before you join.

Who cannot join the trial?

7 criteria

Being pregnant, in labor, or breastfeeding.
Being in jail or a similar place because of a court or government decision.
Being under psychiatric (mental‑health) care.
Living in a hospital, nursing home, or other care facility for reasons other than the research.
Being an adult who is under a legal protection such as guardianship or curatorship (someone else makes legal decisions for you).
Already taking part in another clinical trial that is still active or has a required waiting period.
Having a medical reason that makes a PET scan unsafe, such as severe claustrophobia (fear of being in a small space).

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Verified sites

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Centre Hospitalier Lyon Sud
Verified
Pierre Benite, France

Trial locations

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Investigated drugs

[68Ga]FAPI-46 is a special imaging agent that contains a tiny amount of the radioactive material gallium‑68. It is given by injection into a vein and travels through the bloodstream to attach to a protein that is often present on cancer cells. During a PET/CT scan, the tiny radioactive signal from this agent shows up on the images, allowing doctors to see where cancer has spread, especially when standard scans do not give clear results. This agent is used only for diagnostic purposes and does not treat the disease.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

[68Ga]FAPI-46 - It is given by intravenous injection as a sterile solution for injection, delivering a small amount of Gallium‑68 radioactivity per kilogram of body weight. The agent is still investigational and is not yet approved for routine clinical use, but it is being studied in several imaging trials. It is used to help find cancer spread, especially in patients with invasive lobular breast cancer, by highlighting areas where a protein called fibroblast activation protein is present. The Gallium‑68 attached to the molecule emits signals that a PET scanner can detect, allowing doctors to see tumors, and it belongs to the class of radiopharmaceuticals called PET tracers.

Investigated diseases

Invasive lobular carcinoma of the breast - A type of breast cancer that begins in the milk‑producing lobules and grows by spreading in thin strands between cells. It often forms multiple small areas that can be difficult to feel as a lump. The tumor can extend into surrounding breast tissue and may involve nearby lymph nodes. Over time it can spread to other parts of the body through the bloodstream or lymphatic system. The disease may appear in both breasts or recur after removal.