AuthorisedTherapeutic exploratory (Phase II)Interventional

[68]GA-FAPI-46 PET/CT for the diagnosis of metastatic lesions in patients with lobular breast cancer (ICL). FAPICL

Invasive lobular breast cancer can be difficult to see on standard scans because of how the cells grow and spread through tissue. Regular PET scans use a tiny amount of radioactive sugar to find tumours, but lobular cancer cells do not always absorb much sugar, which means areas of spread can be missed. This Phase II clinical trial tests an experimental imaging dye called [68Ga]FAPI-46. Instead of using sugar, this dye targets a specific protein found around cancer cells, helping them light up clearly on a PET/CT scanner. Researchers want to see if this new scan can detect cancer spread in women whose standard scans appeared clear or uncertain. If you join, you will have the new scan so doctors can compare it to your regular tests. Taking part is completely voluntary and helps researchers find better ways to detect and monitor lobular breast cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Hospices Civils De Lyon

Enrolment target

Start

25 Aug 2026

invasive lobular carcinomas of the breast

What is this study about?

Invasive lobular breast cancer begins in the milk-producing glands of the breast. Unlike other breast cancers that form distinct, firm lumps, lobular cancer cells often grow in single lines through the tissue. Because of this unusual growth pattern, lobular cancer can be harder to spot on routine mammograms and standard body scans.

When doctors check whether cancer has spread to other parts of the body, they often use a PET/CT scan. Standard scans use a mild radioactive sugar called FDG. Fast-growing tumours usually consume lots of sugar and show up brightly. However, lobular breast cancer cells are often slow-growing and do not take up much sugar. This means standard scans can sometimes look negative or unclear, even when small amounts of cancer are present.

This trial investigates a new imaging tracer called [68Ga]FAPI-46. This tracer looks for a specific protein, known as FAP, which is found in high amounts in the supportive tissue surrounding tumour cells. By binding to this protein, the new scan aims to produce a clearer, more detailed picture of any secondary cancer spots that standard scans might have missed.

Doctors will compare the pictures taken with this new scan against standard scans and, where suitable, small tissue samples (biopsies). The overall goal is to improve how doctors detect secondary lobular breast cancer. Spotting cancer spread earlier and more reliably allows care teams to choose the most effective, personalised treatment plans for their patients.

Key takeaways

This trial tests a new PET/CT scan tracer called FAPI-46 for women with invasive lobular breast cancer.
Lobular cancer can be difficult to see on standard scans, and the new tracer aims to highlight hidden areas of spread.
The study involves an injection of the imaging dye followed by a 20 to 30-minute scan.
Taking part will not replace your standard cancer treatments.
Participation is completely voluntary, and you can withdraw at any time without affecting your standard NHS care.

Who may be eligible?

This trial is designed specifically for adult women who have been diagnosed with invasive lobular breast cancer.

It is mainly open to patients whose doctors need to check whether the cancer has spread to other areas of the body, particularly if standard scans have not provided a clear answer or have shown no clear signs of cancer despite ongoing symptoms.

To take part, you must be 18 years of age or older. You will also need to be well enough to attend hospital imaging appointments and lie comfortably still in a scanner. Your hospital doctor or the trial team will review your full medical history to confirm whether this study is safe and suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am a female aged 18 or older.
I have been diagnosed with invasive lobular breast cancer.
My doctor needs to assess whether my cancer has spread to other parts of my body.
I am able to attend a specialist hospital and lie still in a scanner for up to 30 minutes.
I am not pregnant or breastfeeding.

Answer every question to see your result.

What does participation involve?

Taking part in this imaging study usually involves one or two visits to a specialist hospital imaging department. During your visit, a nurse or technician will place a small needle into a vein in your arm to give you an injection of the new [68Ga]FAPI-46 tracer. You will then rest quietly for around an hour while the dye travels through your body and settles around any active cells. After this waiting period, you will lie flat on an imaging bed that gently moves through the PET/CT scanner. The scan itself takes around 20 to 30 minutes and is painless. The team will monitor you for a short time afterwards before you go home. If the scan finds any suspicious areas, your doctor may suggest a routine biopsy to confirm what the scan has shown. The study team will follow your progress and compare your new scan with your routine NHS medical records.

Potential risks and benefits

Taking part in this study may not directly cure your cancer, but the scan could give your doctors clearer information about your condition to help guide your treatment. You will also be helping to improve cancer detection for other women in the future. The risks are generally low. The scan uses a small amount of radiation, similar to other standard medical scans. You might experience minor bruising or discomfort where the needle enters your vein, and very rarely, people may have an allergic reaction to the imaging dye. Taking part is entirely your choice. You are free to say no or leave the study at any point, and your regular NHS medical care will continue as normal.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is a PET/CT scan?

A PET/CT scan combines two types of pictures. A CT scan shows the physical structure of your organs, while a PET scan shows how active your cells are using a small amount of a safe, glowing dye.

Will the radioactive dye make me dangerous to others?

The amount of radiation is very small and breaks down quickly. You will receive simple advice, such as avoiding close, prolonged contact with small children or pregnant women for a few hours after the test.

Does having this scan mean my cancer has spread?

No. The scan is a diagnostic test to look closely at your body. A scan is done to check for any signs of spread, but it does not mean cancer has definitely spread.

Does this trial replace my normal cancer treatment?

No. This is an imaging study rather than a treatment trial. You will continue to receive your standard cancer treatments and follow-up care as planned by your medical team.

Will I have to pay to take part?

No, clinical trials in the UK do not charge patients for study tests. You may also be eligible for help with travel costs to and from the hospital.