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Evaluation of 68Ga-FAPI PET/CT scan effectiveness in monitoring treatment response in patients with peritoneal metastases receiving intraperitoneal chemotherapy

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What is this trial about?

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

This study focuses on patients with peritoneal metastases, a condition where cancer cells spread to the lining of the abdominal cavity. The research evaluates a new imaging method using 68Ga-FAPI-46, which is a special solution given through an intravenous injection into a vein. This imaging agent helps create detailed pictures of the inside of the body when used with special scanning equipment.

The purpose of the study is to determine how well PET/CT scans using this imaging solution can show how tumors are responding to treatment in patients receiving chemotherapy directly into their abdomen. During the study, participants will receive the imaging solution and undergo scanning procedures to create detailed pictures of their cancer before and after treatment.

The treatment involves giving chemotherapy medication directly into the abdominal cavity, which may be combined with regular chemotherapy given through the bloodstream. The study will last approximately two years, during which patients will receive up to two doses of the imaging solution, with each dose calculated based on body weight.

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 PET/CT scan
You will receive an intravenous injection of a special imaging substance called 68GA-FAPI-46
A PET/CT scan will be performed to create detailed images of your peritoneal metastases (cancer spread in the abdominal lining)
This scan serves as a baseline measurement before starting treatment
Step 2
Treatment phase
You will begin receiving intraperitoneal (IP) chemotherapy (medication delivered directly into the abdominal cavity)
The treatment may include a combination of IP and regular chemotherapy
Treatment will be administered multiple times according to your specific treatment plan
Step 3
Follow-up PET/CT scan
After completing the prescribed treatment cycles, you will receive another injection of 68GA-FAPI-46
A second PET/CT scan will be performed to evaluate changes in tumor size and treatment response
The images will be compared with your initial scan to measure the effectiveness of treatment
Step 4
Final assessment
Your case will be reviewed by medical specialists to evaluate treatment response
A second laparoscopy (minimally invasive surgery) may be performed to examine the treatment results
The study will compare the accuracy of PET/CT scanning with other evaluation methods

Who can join the trial?

6 criteria

Must be scheduled to begin repeated IP chemotherapy (chemotherapy delivered directly into the abdominal cavity) for peritoneal metastases (cancer that has spread to the lining of the abdomen)
Must have a WHO performance score of 0 to 1 (this means you must be able to carry out all normal activities or have only minor limitations in strenuous activities)
Must be 18 years of age or older
Must be able to understand and sign an informed consent form (a document explaining all study procedures and potential risks)
Can be either male or female
Must not be part of any vulnerable population groups (such as prisoners or persons unable to give consent)

Who cannot join the trial?

11 criteria

Age below 18 years old
Pregnant or breastfeeding women
Claustrophobia (fear of confined spaces) that would prevent lying still in the PET/CT scanner
Unable to lie flat for approximately 30 minutes during the imaging procedure
Known allergy or hypersensitivity to the radioactive tracer (imaging substance) used in the study
Weight exceeding the PET/CT scanner's weight limit (usually 350 pounds/160 kg)
Unable to provide informed consent
Participation in another clinical trial that could interfere with this study
Lack of planned intraperitoneal chemotherapy (chemotherapy delivered directly into the abdominal cavity)
Medical conditions that make it unsafe to undergo PET/CT scanning
Unable to follow study procedures or attend scheduled visits

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Verified sites

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Responsive
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Rotterdam, The Netherlands

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Investigated drugs

68Ga-FAPI is a radioactive imaging agent used in PET/CT scans. It helps doctors see certain types of cells in the body, particularly those associated with cancer and specifically peritoneal metastases (cancer spread to the lining of the abdomen). This tracer attaches to proteins called fibroblast activation proteins (FAP), which are often found in higher amounts around tumors. The imaging helps doctors evaluate how well a patient is responding to chemotherapy treatment. Note: This trial appears to be an imaging study using this radioactive tracer to monitor treatment response, rather than testing new medications. The chemotherapy mentioned in the trial objective is part of the patients' standard treatment, not the investigational product.

(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 – A radioactive diagnostic imaging agent administered intravenously for PET/CT scanning, specifically designed to bind to fibroblast activation protein (FAP) which is highly expressed in cancer-associated fibroblasts. This tracer is currently being investigated in clinical trials for its ability to evaluate treatment response in patients with peritoneal metastases undergoing intraperitoneal chemotherapy. As a nuclear medicine imaging agent, it combines the radioactive gallium-68 isotope with a FAP inhibitor molecule to create detailed images of cancer spread and treatment effectiveness in the peritoneal cavity, offering potentially superior visualization compared to conventional imaging methods.

Investigated diseases

Peritoneal Metastases - A condition where cancer cells spread to the peritoneum, which is the thin layer of tissue that lines the abdomen and covers most internal organs. The cancer cells form small tumor deposits on the peritoneal surface, which can grow and multiply over time. These metastases typically develop from primary cancers in nearby organs such as the colon, ovaries, or stomach. The condition can cause fluid buildup in the abdomen and may affect the function of abdominal organs. As the disease progresses, the tumor deposits can spread throughout the peritoneal cavity.