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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 study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Karolinska University Hospital Solna Sweden
St. Antonius Ziekenhuis Nieuwegein The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Sweden Sweden
Recruiting
27.03.2026
The Netherlands The Netherlands
Not yet recruiting
27.03.2026

Trial locations

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.

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.

Trial ID:
2024-519384-18-00
Protocol code:
GE-282-201
NCT ID:
NCT07219238
Trial Phase:
Therapeutic use (Phase IV)

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