Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging of Patients with Ovarian Cancer

This research is looking into how effective two special types of body scans, called FAPI PET/CT and FDG PET/CT, are for people with ovarian cancer. The doctors want to see how accurately these scans can find the cancer in different parts of the body, like the main tumour, nearby lymph nodes, and any areas where it might have spread. They'll compare the scan results with what they find from tissue samples (biopsies). The main goal is to find out if the FAPI PET/CT scan can give a clearer picture of the cancer's stage, both when it's first diagnosed and after chemotherapy, potentially helping doctors make better treatment plans. It's hoped that this new scan could lead to more tailored and effective care for patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Aalborg University Hospital

Enrolment target

Start

11 Sep 2023

Ovarian Cancer

What is this study about?

Imagine your doctor needs the clearest possible picture of your ovarian cancer – where it is, how big it is, and if it has spread. This study is testing two kinds of special full-body scans, FAPI PET/CT and FDG PET/CT, to see which one does a better job at showing these details. Think of it like comparing two different cameras to see which one takes the most accurate and helpful photos inside your body.

Doctors want to compare the results from these scans with what they learn from tissue samples (biopsies) and surgery. This helps them understand if the scans are correctly identifying where the cancer is. They will look at whether these scans can accurately tell them the stage of the cancer, both when it's first found and after you've had chemotherapy. Knowing the exact stage is really important for deciding the best treatment plan for you.

The hope is that if one of these scans, especially the newer FAPI PET/CT, gives a much clearer picture, it could help doctors make more informed decisions about your care. This could mean adjusting treatments to be more effective for your specific situation. The study will also watch to see if patients experience any discomfort during the FAPI scan.

Key takeaways

The study compares two advanced body scans (FAPI PET/CT and FDG PET/CT) for ovarian cancer.
It aims to see which scan is better at finding and tracking ovarian cancer spread.
Results from scans will be compared with tissue samples and surgery findings.
The goal is to help doctors make more accurate treatment decisions for ovarian cancer patients.
This is a Phase II study, meaning it's exploring whether the new scan is useful.
Only women aged 18 and over with ovarian cancer can take part.

Who may be eligible?

This study is looking for women who are 18 years old or older and have ovarian cancer. This includes women who have just been diagnosed with ovarian cancer and those who are being checked again after having chemotherapy.

More specific details about your health and the type of ovarian cancer you have would be discussed with your doctor to see if this study is suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman?
Are you 18 years old or older?
Have you been diagnosed with ovarian cancer?
Are you either just starting treatment, or being checked again after chemotherapy for ovarian cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive different types of body scans. This includes the new FAPI PET/CT scan and a standard FDG PET/CT scan. These scans involve receiving a small amount of a special liquid into your vein. Doctors will also collect information from any tissue samples and surgical procedures you might have as part of your normal care. Your heart rate and blood pressure will be checked before and after one of the scans. The total duration of your involvement would depend on whether you are being assessed for the first time or after chemotherapy, but it aligns with your standard care pathway for ovarian cancer staging and re-staging.

Potential risks and benefits

Taking part might offer the benefit of receiving advanced imaging that could potentially add to the information doctors have about your cancer. However, there are no guarantees that you will personally benefit from participating. As with any medical procedure, there are potential risks, such as discomfort from injections or the small exposure to radiation from the scans, which your doctor will explain fully. Remember, participating in any clinical trial is completely voluntary, and you have the right to withdraw at any time without affecting your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Denmark

Common questions

What is a PET/CT scan?

A PET/CT scan is a type of imaging test that combines two scans: a PET scan (Positron Emission Tomography) and a CT scan (Computed Tomography) to get detailed pictures of the inside of your body and how your cells are working.

What is FAPI and FDG?

FAPI and FDG are special 'tracers' (mildly radioactive substances) that are injected into your body before a PET/CT scan. They help highlight cancer cells on the scan. This study is comparing how well different tracers work.

Will this study change my cancer treatment?

This study aims to investigate if the FAPI PET/CT scan could lead to different treatment choices in the future. For now, the main goal is to compare its accuracy with existing methods. Any changes to your direct treatment would be discussed by your medical team based on your overall condition and standard guidelines.

Is there any pain involved with the scans?

You might feel a small sting when the tracer liquid is injected, similar to a blood test. The scans themselves are usually painless, but you'll need to lie still for a period, which some people might find uncomfortable.

How long does each scan take?

Typically, you'll need to wait for a while after the injection for the tracer to spread through your body, and the scan itself (where you lie in the machine) can take anywhere from 15 to 45 minutes, depending on the type of scan.