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Study on 68Ga-FAPI-46 for Imaging Pancreatic, Stomach, Bile Duct, and Ovarian Cancers in Patients with Solid Tumors

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on improving the diagnosis of certain types of cancer, specifically those affecting the pancreas, stomach, bile ducts, and ovaries. The study uses a new imaging method called FAPI-PET, which involves a special tracer known as 68Ga-FAPI-46. This tracer is a solution that is injected into the body and helps to highlight tumors during imaging tests. The purpose of the study is to enhance the non-invasive diagnosis of these cancers.

Participants in the study will undergo imaging with the FAPI-PET method to see how well it can detect and stage tumors compared to traditional imaging techniques. The study will also look at how the tracer interacts with certain proteins in the tumor tissue, which may help in understanding the nature of the cancer. The imaging process is expected to provide detailed pictures of the tumors, which can assist doctors in planning treatment.

The study will monitor participants over time to assess the effectiveness of the FAPI-PET imaging in predicting outcomes such as disease progression and survival. This will involve follow-up checks at various intervals to gather information on the participants' health status. The trial aims to provide valuable insights into the use of this new imaging technique for better cancer diagnosis and management.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility is based on suspected cancer in the pancreas, stomach, bile ducts, or ovaries, with plans for surgical removal and histopathological confirmation.
Step 2
Consent
Written consent is required to participate in the study. This ensures understanding of the study's purpose and procedures.
Step 3
Administration of tracer
The tracer 68Ga-FAPI-46 is administered intravenously. This is a solution for injection used to enhance imaging of tumors.
The purpose of the tracer is to improve the non-invasive diagnosis of malignancies in the specified organs.
Step 4
PET/CT imaging
After the tracer is administered, a PET/CT scan is performed. This imaging technique helps visualize the tumors and assess their characteristics.
The scan evaluates the uptake of the tracer in the tumor, which is compared to other diagnostic methods.
Step 5
Surgery and confirmation
Surgical removal of the tumor is scheduled. This step is crucial for obtaining a histopathological confirmation of the diagnosis.
The surgery provides tissue samples that are analyzed to confirm the presence and type of cancer.
Step 6
Follow-up assessments
Follow-up assessments are conducted to monitor health status and evaluate the effectiveness of the imaging technique.
These assessments include recording disease-free survival and overall survival at 1, 2, and 5 years.
Step 7
Evaluation of imaging technique
The study evaluates the FAPI-PET/CT as a staging tool, comparing it to conventional radiology.
The accuracy of the imaging technique is assessed against histopathological results to differentiate between benign and malignant lesions.
Step 8
Monitoring of adverse events
Throughout the study, any adverse events or reactions are monitored and recorded.
This includes any unexpected serious adverse reactions that may occur during the trial.

Who can join the trial?

5 criteria

The person must have given written consent to participate in the study. This means they have signed a document agreeing to be part of the research.
The person must have a suspected cancer of the pancreas, stomach, bile ducts, or epithelial ovarian cancer. This suspicion is based on a combination of tests, including blood tests, tissue tests, and imaging tests like scans or X-rays.
The person must be scheduled for surgery to remove the suspected cancer, and the diagnosis must be confirmed by examining the tissue under a microscope, which is called a histopathological confirmation.
Both men and women can participate in the study.
The study is open to adults, which typically means people aged 18 and older.

Who cannot join the trial?

10 criteria

Patients who are currently pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to any of the study medications are excluded.
Patients who have had another type of cancer within the last 5 years, except for skin cancer that is not melanoma, are not eligible.
People with serious heart conditions, such as heart failure or recent heart attack, cannot join the study.
Individuals with uncontrolled high blood pressure are excluded.
Patients with severe liver or kidney disease cannot participate.
Anyone who is currently participating in another clinical trial is not eligible.
Individuals with a history of substance abuse within the past year are excluded.
Patients who have had major surgery within the last 4 weeks cannot join the study.
People with any other medical condition that the study doctors believe would make participation unsafe are not eligible.

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Verified sites

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Helsinki University Central Hospital
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Helsinki, Finland
Karolinska University Hospital
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Solna, Sweden

Trial locations

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Investigated drugs

68Ga-FAPI-46 is a novel tracer used in PET imaging to help diagnose tumors with a strong desmoplastic reaction. This tracer targets the fibroblast activation protein, which is often present in the tissue surrounding certain types of tumors, such as those in the pancreas, bile ducts, stomach, and ovaries. By using this tracer, doctors aim to improve the non-invasive diagnosis of these malignancies, making it easier to detect and assess the extent of the cancer.

(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-46 – This medication is administered through an injection and is used in PET imaging to help diagnose certain types of cancer, including those in the pancreas, bile ducts, stomach, and ovaries. It is currently being studied in clinical trials to enhance non-invasive cancer diagnostics. The main therapeutic indication is to improve the detection of tumors with a strong desmoplastic reaction. At the molecular level, it works by targeting the fibroblast activation protein, which is often overexpressed in cancer-associated fibroblasts, allowing for better imaging of tumors. It is classified as a diagnostic radiopharmaceutical.

Investigated diseases

Pancreatic Cancer
This disease involves the growth of malignant cells in the tissues of the pancreas. It often begins in the cells that produce digestive juices or hormones. As it progresses, it can invade nearby organs and spread to distant parts of the body. Symptoms may include jaundice, weight loss, and abdominal pain. The disease can be challenging to detect early due to its deep location in the abdomen.
Stomach Cancer
Also known as gastric cancer, this disease starts in the lining of the stomach. It can develop slowly over many years and may initially cause symptoms like indigestion or stomach discomfort. As it advances, it can lead to more severe symptoms such as nausea, vomiting, and weight loss. The cancer can spread to nearby organs and lymph nodes.
Bile Duct Cancer
This cancer, also known as cholangiocarcinoma, occurs in the bile ducts, which are tubes that carry bile from the liver to the gallbladder and small intestine. It can cause symptoms like jaundice, itching, and abdominal pain. The disease may spread to nearby tissues and organs. It is often diagnosed at an advanced stage due to its subtle early symptoms.
Epithelial Ovarian Cancer
This type of cancer originates in the epithelial cells on the surface of the ovary. It is the most common form of ovarian cancer and can spread to the pelvis and abdomen. Symptoms may include bloating, pelvic pain, and changes in bowel habits. The disease often goes undetected until it has spread within the pelvis and abdomen.