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A study to evaluate the use of FAPI-46 (68Ga) imaging to detect peritoneal cancer spread in patients with colorectal, gastric, ovarian, or pancreatic cancer

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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 Colorectal Cancer, Gastric Cancer, Ovarian Cancer, or Pancreatic Cancer. These individuals may also have Peritoneal Carcinomatosis, which is a condition where cancer cells spread to the lining of the abdomen. The purpose of the study is to evaluate how well a new imaging method can detect this spread. The imaging technique uses an injection of GEH300079 (68Ga) followed by a PET/CT scan, which is a specialized imaging test that combines a Positron-Emission Tomography scan and a computed tomography scan to create detailed pictures of the body.

During the study, participants will receive an intravenous injection, meaning the substance is delivered directly into a vein. After the injection, the imaging process will be performed to look for signs of cancer in the abdominal area. The effectiveness of the GEH300079 (68Ga) injection will be compared to standard imaging methods currently used in medical practice to see if this new method provides more accurate information about the presence and location of cancer cells.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Diagnostic imaging procedure
An intravenous injection of FAPI-46 (68Ga) is administered. the dosage is 300 MBq (megabecquerels).
A PET/CT scan, which is a medical imaging test that combines positron-emission tomography and computed tomography, is performed to look for peritoneal carcinomatosis. this is a condition where cancer has spread to the lining of the abdomen.
The scan is used to evaluate how well the imaging can detect the presence and location of cancer cells in the abdomen.
Step 2
Safety and health monitoring
vital signs, including blood pressure, respiratory rate (breathing speed), heart rate, and body temperature, are measured to monitor health.
An electrocardiogram (ECG) is performed to check the electrical activity of the heart.
A physical examination is conducted to observe any changes in physical health.
laboratory tests, such as urinalysis (testing urine) and other clinical blood parameters, are performed to monitor how the body responds to the injection.

Who can join the trial?

9 criteria

You must be 18 years of age or older.
You must provide signed informed consent, which means you have read and agreed to take part in the study after being told all the details.
You must have a confirmed diagnosis through histopathology, which is a process where a doctor examines tissue under a microscope to prove the presence of cancer.
The cancer must be located in the colorectal (large intestine), gastric (stomach), or ovarian area, or you must have PDAC, which stands for pancreatic ductal adenocarcinoma, a specific type of pancreatic cancer.
You must have peritoneal carcinomatosis, which is when cancer cells spread to the peritoneum, the thin layer of tissue that lines the inside of your abdomen and covers your organs, or you are suspected of having it based on scans or physical exams.
You must be scheduled for peritoneal surgery, such as laparoscopy (a surgery using small cuts and a camera) or surgical exploration, with the goal to cure the condition or investigate the area.
You must either have not received any previous treatment for this cancer or have completed systemic treatment, such as neoadjuvant chemotherapy (medicine used to shrink a tumor before surgery).
Your ECOG performance status must be 2 or less, which is a scale used by doctors to measure how much an illness affects your daily activities and ability to function.
You must be able and willing to follow all the rules and steps required for the study.

Who cannot join the trial?

14 criteria

You cannot participate if you are pregnant, breast-feeding, or if you are sexually active and not using a reliable form of birth control (methods used to prevent pregnancy) from 30 days before the study until 30 days after receiving the study drug.
You cannot join if you have serious co-morbidities, which are other major health conditions or illnesses that are not cancer, which the doctor believes could make the study unsafe for you or prevent the study from reaching its goals.
You cannot participate if you have taken or plan to take any other investigational agent, which is a new medicine being tested in a study, within 28 days before your first imaging visit or while participating in this study.
You cannot join if you have a known or suspected hypersensitivity, which means an allergy or extreme sensitivity, to any of the ingredients used in the study drug GEH300079 (68Ga).
You cannot participate if you have severe claustrophobia (an intense fear of being in enclosed spaces), if you cannot lie flat, if you cannot fit inside the scanner, or if you cannot tolerate the PET/CT scan (a medical imaging test) for any reason.
For the Phase 3 part of the study, you cannot join if you were already a participant in Phase 2 of this same study.
You cannot participate if you have a known medical condition that the doctor believes will interfere with the study procedures.
You cannot join if you require any medical treatment or intervention that would cause a delay in starting the study.
You cannot participate if you have non-resectable extra-abdominal metastasis, which means cancer that has spread to areas outside the abdomen and cannot be removed by surgery, or if you have more than three hepatic metastases, which means more than three areas of cancer that have spread to the liver.
You cannot join if your expected life expectancy is too short to allow you to finish the study.
You cannot participate if you have an active infection caused by bacteria, viruses, or fungi that requires medicine taken throughout the entire body (systemic therapy), though medicines applied only to the skin are allowed.
You cannot join if you have renal function impairment, which means your kidneys are not working correctly, measured by an estimated glomerular filtration rate (a test that shows how well your kidneys filter blood) of less than 60 mL/min in Phase 2 or less than 30 mL/min in Phase 3.
You cannot participate if you have severe hepatic function impairment, which means your liver is not working correctly, defined by having aspartate aminotransferase or alanine aminotransferase (liver enzymes) more than five times the normal limit, or total bilirubin (a substance made by the liver) more than three times the normal limit.
You cannot join if you have Crohn’s disease, ulcerative colitis, or sarcoidosis, which are all different types of inflammatory conditions.

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Verified sites

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Karolinska University Hospital
Solna, Sweden
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St. Antonius Ziekenhuis
Nieuwegein, The Netherlands

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Investigated drugs

FAPI-46 (68Ga) is a special radioactive substance used during a PET/CT scan. When injected into the bloodstream, it travels through the body to help doctors create detailed images. This imaging technique is used to help identify the presence of cancer spreading within the lining of the abdomen.

(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

FAPI-46 (68Ga) - This medication is an injectable substance administered directly into a vein to be used during specialized medical imaging. It is currently being studied in clinical trials to improve how doctors detect cancer spread within the abdomen, specifically for patients with colorectal, gastric, ovarian, or pancreatic cancers. As a diagnostic tracer, it works by targeting and attaching to specific proteins that are highly active on the surface of many cancer cells, allowing them to glow brightly on a PET/CT scan. This substance is classified as a radiopharmaceutical used for molecular imaging.

Investigated diseases

Colorectal Cancer
This disease occurs when abnormal cells form in the tissues of the colon or rectum. It often begins as small growths called polyps on the inner lining of the digestive tract. Over time, these growths can transform into malignant tumors that grow into the surrounding layers of the organ. The cancer can eventually spread to nearby lymph nodes or other parts of the body.
Gastric Cancer
This condition involves the uncontrolled growth of abnormal cells in the lining of the stomach. It typically begins in the mucosal layer and can grow deeper into the stomach walls as it advances. The disease may progress by spreading to nearby organs or through the lymphatic system.
Ovarian Cancer
This disease starts in the ovaries, which are the female reproductive organs. It often involves the rapid multiplication of abnormal cells within the ovarian tissue. As the disease moves forward, it can involve the abdominal cavity or spread to other organs.
Pancreatic Cancer
This condition is characterized by the growth of malignant cells within the pancreas, an organ located behind the stomach. The disease often starts in the ductal cells that line the pancreatic tubes. It can progress by invading adjacent tissues or spreading to distant sites in the body.