In short
GA68-ONCOFAP is an investigational radioactive imaging agent being studied to detect cancer. It is a chemically synthesised substance given by intravenous injection. One Phase 2 trial is testing it in 65 people with pancreatic, colorectal, gastric, breast or ovarian cancer to see how well it can find cancer in the peritoneum.
Key points
- GA68-ONCOFAP is an investigational imaging agent, not an authorised medicine.
- It is being tested in a Phase 2 trial with 65 participants.
- The trial focuses on pancreatic, colorectal, gastric, breast and ovarian cancers.
- The study measures how accurately the agent detects cancer in the peritoneum.
- The product is given as a solution for injection into a vein.
- The trial is currently Authorised.
What is GA68-ONCOFAP?
GA68-ONCOFAP is an investigational radioactive imaging agent. It is a chemically synthesised substance, not a medicine used to treat cancer. The product name in the trial record is [68Ga]BED003 injection. It has no marketing authorisation in the product records, meaning it is still being studied and is not approved for routine use. The company supplying the product is Blue Earth Diagnostics Ltd.
How does GA68-ONCOFAP work?
The trial record does not describe the molecular mechanism of GA68-ONCOFAP. It is a radioactive imaging agent used with PET/CT scanning. In the ongoing trial, the aim is to see how well the agent can detect cancer in the peritoneum, the membrane lining the inside of the abdomen. The substance is classified in the therapeutic area of neoplasms, meaning it is studied in cancer.
Which conditions is it studied for?
The Phase 2 trial includes people with five types of cancer:
- Colorectal cancer (CRC) — cancer of the colon or rectum.
- Gastric cancer (GC) — cancer of the stomach.
- Pancreatic ductal adenocarcinoma (PDAC) — the most common type of pancreatic cancer.
- Invasive lobular breast cancer (ILC) — a type of breast cancer that begins in the milk-producing glands.
- Epithelial ovarian cancer (EOC) — cancer that starts in the layer of cells covering the ovary.
How is GA68-ONCOFAP given?
GA68-ONCOFAP is given as a solution for injection into a vein (intravenous use). In the trial, the dose used is 240 MBq (megabecquerels), a unit that measures radioactivity. After injection, a PET/CT scan is performed to create images of the body.
What do the clinical trials show?
One trial is registered for GA68-ONCOFAP. It is a Phase 2 interventional study with 65 planned participants. The trial is currently Authorised, meaning it has received approval to proceed. The study is investigating the diagnostic performance of the agent in the peritoneum. The main measures are sensitivity and specificity: sensitivity describes how well the test finds cancer that is present, and specificity describes how well it avoids false alarms in people without cancer. The results are compared to a composite standard of truth at the region level, specifically the peritoneum. People eligible for the trial are those with one of the five cancer types studied.
What side effects are known?
The trial record does not report side effects for GA68-ONCOFAP. The study is designed to assess diagnostic performance, not safety as a primary outcome.