Study on [18F]PSMA-11 PET Imaging for Patients with Advanced Thyroid and Head and Neck Cancer

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What is this study about?

This clinical trial is focused on studying two types of cancer: head and neck squamous cell carcinoma and thyroid carcinoma. The treatment being investigated is a special imaging agent called [18F]PSMA-11, which is used in a type of scan known as a PET scan. This agent helps doctors see cancerous lesions more clearly on the scan. The purpose of the study is to see how well this imaging agent works in detecting cancer in patients with advanced forms of these diseases.

Participants in the study will receive an injection of the [18F]PSMA-11 solution, which is administered through a vein. After the injection, a PET scan will be performed to capture images of the cancerous areas. The study aims to observe how much of the imaging agent is taken up by the cancerous lesions, which can help in understanding the extent of the disease. This process will be repeated as needed to gather enough information for the study.

The study will last for a period during which all necessary scans and evaluations will be completed. The results will help determine the effectiveness of [18F]PSMA-11 in providing clear images of cancerous lesions in patients with advanced head and neck squamous cell carcinoma and thyroid carcinoma. This information could be valuable in improving the diagnosis and treatment planning for these types of cancer in the future.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate and understand the details of the study.

You must be at least 18 years old and have at least one measurable lesion of interest that is 1.0 cm or larger on medical imaging.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility and gather baseline information. This may include medical imaging to identify lesions of interest.

3 administration of medication

You will receive an intravenous injection of a solution called [18F]PSMA-11. This is a special type of medication used for imaging purposes.

The injection is administered directly into your vein, and the process is quick and straightforward.

4 PET scan

After the injection, a PET scan will be performed. This scan helps to visualize the uptake of the [18F]PSMA-11 in your body.

The scan is non-invasive and involves lying still while the machine takes images.

5 follow-up assessments

Follow-up assessments will be conducted to monitor the uptake of the medication in lesions and organs. These assessments are done within 12 months after the last trial-specific intervention.

The primary goal is to count the lesions with significant uptake, while secondary goals include measuring uptake values in lesions and organs.

6 completion of trial

The trial is expected to be completed by November 24, 2026. All endpoints are measured within 12 months after the last trial-specific intervention.

You will be informed about the results and any relevant findings from the study.

Who Can Join the Study?

Must be 18 years of age or older.
Must be willing and able to provide written informed consent. This means you understand the study and agree to participate.
Must have at least one measurable lesion (an area of abnormal tissue) that is at least 1.0 cm in size, as seen on medical imaging like a scan.

Who Cannot Join the Study?

Patients with any other type of cancer besides head and neck squamous cell carcinoma or thyroid carcinoma cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Universitair Ziekenhuis Gent	Gent	Belgium

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	24.07.2023

Trial locations

Investigated drugs:

Gozetotide Alf-18

[18F]AlF-PSMA-11 is a special type of imaging agent used in this clinical trial. It is designed to help doctors see certain types of cancer cells more clearly during a PET scan, which is a type of imaging test. This agent targets a specific protein found on the surface of some cancer cells, particularly in thyroid and head and neck cancers. By highlighting these cells, it helps doctors better understand the extent of the disease and how it is affecting the body. This can be very useful in planning treatment and monitoring how well the treatment is working.

Investigated diseases:

Head and Neck Squamous Cell Carcinoma – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck. It typically begins in areas such as the mouth, throat, and nose. The disease progresses as the cancer cells grow and form tumors, which can invade nearby tissues. Over time, it may spread to lymph nodes and other parts of the body. The progression can lead to symptoms like difficulty swallowing, changes in voice, and persistent sore throat. As the disease advances, it can affect breathing and cause significant discomfort.

Thyroid Carcinoma – This is a cancer that starts in the thyroid gland, which is located at the base of the neck. It often begins as a small, painless lump in the thyroid. As the disease progresses, the cancer cells can grow and form larger tumors. These tumors may spread to nearby lymph nodes and other parts of the body. The progression can lead to symptoms such as a noticeable lump in the neck, changes in voice, and difficulty swallowing. Over time, it can cause hormonal imbalances and affect metabolism.

Trial ID:

2022-503036-13-00

Protocol code:

PANTHEON-18

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on [18F]PSMA-11 PET Imaging for Patients with Advanced Thyroid and Head and Neck Cancer

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