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A study to evaluate the use of [68Ga]BED003 for imaging colorectal, gastric, pancreatic, breast, and ovarian cancers.

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What is this trial about?

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

This study aims to evaluate the effectiveness of a new imaging agent called [68Ga]BED003 for detecting certain types of cancer. The research focuses on several diseases, including Colorectal Cancer, Gastric Cancer, Pancreatic Ductal Adenocarcinoma, Invasive Lobular Breast Cancer, and Epithelial Ovarian Cancer. These conditions involve the uncontrolled growth of abnormal cells in different parts of the digestive system, breasts, or ovaries.

The investigation uses a specialized technique known as PET, which is a type of scan used to visualize how certain substances work inside the body. During the process, the substance [68Ga]BED003 is administered through an intravenous injection, meaning it is delivered directly into a vein. This substance is designed to target a specific protein found in certain tumor environments to help create clearer images. The scans are often combined with a computed tomography, which uses X-rays to create detailed pictures of the body's internal structures.

Participants in the study will undergo imaging to see how well the new substance can identify cancer cells within the peritoneum, which is the thin layer of tissue that lines the inner wall of the abdomen and covers most of the organs. The study will monitor how the imaging agent behaves over time and check for any side effects. The goal is to determine if this new method can provide more accurate information about the presence and location of these cancers compared to standard medical practices.

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
Administration of the test substance
An injection of [68Ga]BED003 is given through a vein. this substance is a test drug used for PET imaging, which is a type of scan that helps doctors see certain activities in the body.
The dose of the injection is 240 megabecquerels.
Step 2
Diagnostic imaging
A PET/CT scan is performed to detect the presence of cancer in the peritoneum, which is the lining of the abdominal cavity.
The diagnostic quality of the images is assessed at two different time intervals: 30 minutes and 60 minutes after the injection is completed.

Who can join the trial?

8 criteria

You must provide informed consent, which means you agree to take part in the study after understanding all the details and risks.
You must be at least 18 years old and younger than 80 years old.
You must have an ECOG performance status of 2 or less, which is a scale used to measure how well you can perform daily activities and how much your cancer affects your physical health.
Women who are able to become pregnant must have a negative blood test at the start and a negative urine pregnancy test before receiving the study medicine.
Women who can become pregnant, and men who are sexually active with them, must agree to use highly effective birth control from the day of the imaging visit until the final safety follow-up call.
You must have a confirmed diagnosis of one of the following cancers: colorectal cancer (cancer of the colon or rectum), gastric cancer (cancer of the stomach), pancreatic ductal adenocarcinoma (a type of cancer in the pancreas), invasive lobular breast cancer (a specific type of breast cancer), or epithelial ovarian cancer (a type of cancer in the ovaries). These diagnoses must be confirmed by histopathology (examining tissue under a microscope) or cytology (examining individual cells).
You must have recent imaging results, such as a CT scan with contrast (a special X-ray that uses a dye to show body parts more clearly) that covers your abdomen and pelvis, performed within 8 weeks of your first visit.
You must meet one of these three conditions: you have not yet received treatment and your cancer is at least stage IIB; you have received neoadjuvant therapy (treatment given before the main treatment, like surgery, to shrink a tumor) and have a surgery or biopsy scheduled within 42 days; or you are suspected of having a recurrence (the cancer has returned) after completing your main treatment.

Who cannot join the trial?

11 criteria

You cannot participate if you have received any radioisotope, which is a type of radioactive substance used in medical imaging, within five physical half-lives—a term referring to the time it takes for half of the substance to leave your body—before the study treatment.
You cannot participate if you have significant renal impairment, which means your kidneys are not working well enough to filter your blood properly.
Female participants who are breastfeeding are not allowed unless they agree to pump and discard breast milk from the time of the injection until the final safety phone call.
You cannot participate if you have taken any other investigational medicinal product, which is a new medicine being tested in a study, within two weeks or five half-lives of the study treatment.
You cannot participate if you have recently used a contrast agent, which is a special dye used during medical scans, within 24 hours for intravenous (injected into a vein) agents or within 5 days for oral (swallowed) agents.
You cannot participate if you have a history of severe claustrophobia, which is an intense fear of being in enclosed or small spaces, or panic attacks.
You cannot participate if you have a known hypersensitivity, which means a known allergy, to the study drug or any of its ingredients.
You cannot participate if you have any medical condition that the investigator (the main doctor in charge of the study) believes would prevent the study from getting accurate results or prevent you from finishing the study.
You cannot participate if you have an autoimmune or inflammatory disorder—conditions where the body's immune system attacks its own healthy cells or causes swelling—that might make the scan images difficult to read, unless the condition is directly related to your cancer.
You cannot participate if you have had abdomino-pelvic (the belly and hip area) or breast irradiation, which is medical treatment using radiation, in the last 3 months.
You cannot participate if you have any implanted foreign material, such as stents (tiny tubes used to keep blood vessels open) or surgical clips, that the doctor believes might make the scan images hard to interpret correctly.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Verified
Fondazione IRCCS San Gerardo Dei Tintori
Monza, Italy
Verified
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Italy

Trial locations

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Investigated drugs

[68Ga]BED003 is an injection used during a PET scan to help doctors see and identify certain types of cancer cells by targeting a specific protein called fibroblast activation protein.

What is already known about the treatment

[68Ga]BED003 - This medication is an injectable liquid that is delivered directly into a person's vein to be used during a PET scan. Currently being studied in clinical research, it is designed to help doctors find and see specific types of cancer, such as those in the colon, stomach, pancreas, breast, or ovaries. It works by targeting and sticking to a specific protein found in the connective tissue around tumors, which helps highlight the cancer cells on medical imaging. This substance is classified as a diagnostic radiopharmaceutical used for molecular imaging.

Investigated diseases

Colorectal cancer
This disease begins when abnormal cells grow in the colon or the rectum. These cells multiply uncontrollably and can form a mass called a tumor. As the condition progresses, the abnormal cells may spread to nearby tissues or other parts of the body.
Gastric cancer
This condition occurs when malignant cells develop in the lining of the stomach. It often starts as small growths in the stomach wall. Over time, these cells can grow deeper into the stomach layers and potentially spread to other organs.
Pancreatic ductal adenocarcinoma
This type of cancer starts in the cells that line the ducts of the pancreas. These cells are responsible for carrying digestive enzymes. The disease typically involves the uncontrolled growth of these cells, which can eventually involve surrounding pancreatic tissue.
Invasive lobular breast cancer
This disease begins in the milk-producing glands, known as lobules, within the breast. Unlike some other types, these cells grow in a single-file pattern through the breast tissue. The term invasive means the cells have moved beyond the lobules into the surrounding breast area.
Epithelial ovarian cancer
This cancer develops from the layer of cells that covers the surface of the ovaries. These cells can transform into malignant cells that grow and multiply. As the disease advances, it can involve the ovaries and potentially spread within the abdominal cavity.