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Study on [68Ga]Ga-FAPI-46 and Fludeoxyglucose (18F) PET/CT Imaging for Evaluating Treatment Response in Patients with Advanced Malignant Melanoma

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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 a type of skin cancer known as malignant melanoma. The study will use a special imaging technique called PET/CT to evaluate how well patients respond to a specific cancer treatment known as immune checkpoint inhibitor therapy. This therapy helps the immune system recognize and attack cancer cells more effectively. The trial will use a tracer called [68Ga]Ga-FAPI-46, which is a solution injected into the body to help highlight cancerous areas during imaging.

The purpose of the study is to see how well the [68Ga]Ga-FAPI-46 PET/CT scan can detect changes in cancerous lesions compared to the standard imaging method using [18F]FDG. The study will also look at how these changes relate to the patient's clinical response to the treatment. Participants will undergo these imaging scans during their treatment to monitor the effectiveness of the therapy.

Additionally, the study will explore how the uptake of [68Ga]Ga-FAPI-46 in healthy tissue might predict potential side effects. Researchers will compare these findings with standard imaging results and analyze blood samples to understand the relationship between the tracer uptake and various biomarkers, which are substances in the blood that can indicate disease activity or response to treatment. The study aims to provide better and faster imaging options for patients with advanced malignant melanoma.

The research process

The trial runs in 7 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 the presence of advanced stage malignant melanoma and ensuring the patient is suitable for immune checkpoint inhibitor therapy.
Eligibility criteria include being over 18 years old, having visible malignant lesions, and being medically suitable for specific therapies such as Pembrolizumab or Ipilimumab+Nivolumab.
Step 2
Baseline imaging
A baseline imaging session is performed using [18F]FDG PET/CT or CT to document the current state of the malignant lesions.
This imaging helps in comparing future changes in the lesions during the trial.
Step 3
Administration of tracer
The patient receives an intravenous injection of the tracer [68Ga]Ga-FAPI-46. This tracer is used for imaging purposes to evaluate the response of the malignant lesions to the therapy.
The administration is done as a solution for injection.
Step 4
Imaging sessions
Total Body (TB) PET/CT scans are conducted using the [68Ga]Ga-FAPI-46 tracer. These scans are used to evaluate the uptake of the tracer in malignant lesions.
The imaging sessions are scheduled at specific intervals to monitor changes in the lesions during the immune checkpoint inhibitor therapy.
Step 5
Therapy monitoring
Throughout the trial, the response to immune checkpoint inhibitor therapy is monitored. This includes evaluating changes in the uptake of the tracer in malignant lesions.
Comparisons are made between the [68Ga]Ga-FAPI-46 PET/CT results and standard [18F]FDG PET/CT results to assess the effectiveness of the therapy.
Step 6
Biomarker analysis
Blood samples are collected to analyze levels of biomarkers, including FAP activity and ECM remodeling biomarkers.
The correlation between these biomarkers and the uptake of the tracer in the PET/CT scans is studied to predict treatment outcomes and potential side effects.
Step 7
End of trial evaluation
At the end of the trial, a comprehensive evaluation is conducted to assess the overall response to the therapy.
The final results are compared with the baseline and interim imaging results to determine the effectiveness of the treatment.

Who can join the trial?

6 criteria

Must be a male or female who is older than 18 years.
Must have a confirmed diagnosis of **metastatic** or **locally advanced malignant melanoma**. This means the skin cancer has spread to other parts of the body or is in a stage that is difficult to treat.
Must have visible cancer spots on special scans called **[18F]FDG PET/CT** or **CT**. These are imaging tests that help doctors see inside the body.
Must be considered **inoperable**, meaning surgery is not an option for treatment.
Must be medically suitable for **immune checkpoint inhibitor therapy (ICT)**, which is a type of treatment that helps the immune system fight cancer. This includes treatments like **Pembrolizumab** or a combination of **Ipilimumab** and **Nivolumab**.
Must be able to read and understand the patient information in Danish to give informed consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

Patients who do not have advanced stage malignant melanoma cannot participate. This is a type of skin cancer that has spread to other parts of the body.
Patients who are not receiving immune checkpoint inhibitor therapy cannot participate. This is a treatment that helps the immune system fight cancer.
Patients who are not within the specified age range cannot participate. The study is open to adults.
Both male and female patients can participate, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population, such as those unable to give consent, are not included in this study.

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Verified sites

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Verified
Herlev Hospital
Herlev, Denmark
Verified
Rigshospitalet
Copenhagen, Denmark

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Investigated drugs

[68Ga]Ga-FAPI-46 is a tracer used in PET/CT scans to help doctors see how well the immune checkpoint inhibitor therapy is working in patients with advanced malignant melanoma. This tracer helps to create detailed images of the body, allowing doctors to evaluate the response to the treatment more effectively.

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/CT scans to evaluate cancer treatment responses. It is currently being studied in clinical trials for its effectiveness in imaging malignant melanoma, a type of skin cancer. The main therapeutic indication is to assess how well immune checkpoint inhibitor therapy is working in patients with advanced melanoma. At the molecular level, [68Ga]Ga-FAPI-46 binds to fibroblast activation protein, which is often found in cancerous tissues, allowing for detailed imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Malignant Melanoma – Malignant melanoma is a type of skin cancer that originates in the melanocytes, the cells responsible for producing melanin, the pigment that gives skin its color. It often appears as a new or changing mole on the skin, which may have irregular borders, multiple colors, or an increase in size. As the disease progresses, it can invade deeper layers of the skin and potentially spread to other parts of the body, including lymph nodes and internal organs. Early stages may be confined to the skin, but advanced stages involve metastasis, where cancer cells travel through the bloodstream or lymphatic system. The progression of malignant melanoma can vary, with some cases remaining localized for years, while others spread rapidly. Regular skin checks and monitoring of moles are important for early detection and management.