Study on Imaging Head and Neck Cancer Using [18F]-Olaparib for Patients with Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of cancer called head and neck squamous cell carcinoma (HNSCC). The study will use a special imaging technique involving a substance called [18F]-olaparib. This substance is a solution for injection that helps in visualizing the cancer cells during a scan. The purpose of the study is to understand how well this imaging technique works and to ensure it is safe for patients.

Participants in the study will receive an injection of [18F]-olaparib, which is also known by the code name AZD-2281. The study will look at how the substance is absorbed by the body and how it interacts with the cancer cells. This will help researchers determine the best time to perform the imaging scan and how the cancer cells respond to the treatment. The study will also compare the uptake of [18F]-olaparib in the tumor with the levels of a protein called PARP-1 in the cancer cells.

The trial will be conducted in stages, with the first stage focusing on finding the right dosage and timing for the imaging, and the second stage continuing to monitor safety and effectiveness. Participants will be monitored for any side effects for up to 30 days after the injection. The study aims to provide valuable information on how this imaging technique can be used to better understand and treat HNSCC.

1 joining the study

Upon joining the study, you will be required to provide a signed written informed consent. This confirms your understanding and agreement to comply with the study protocol.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you have a biopsy-proven head and neck squamous cell carcinoma (HNSCC) and meet other criteria such as age and health status.

3 preparation for imaging

Before the imaging procedure, you will receive an injection of a solution containing [18F]-olaparib. This is administered through an intravenous route, meaning it is injected directly into your vein.

4 imaging procedure

The imaging procedure involves a PET scan, which will help assess the uptake of [18F]-olaparib in your tumor. This helps in understanding the DNA damage response in your body.

5 follow-up assessments

After the imaging, follow-up assessments will be conducted to monitor any adverse effects and to evaluate the correlation between the uptake of [18F]-olaparib and specific protein levels in your tumor.

6 completion of study participation

Your participation in the study will conclude after all necessary data has been collected and any follow-up assessments are completed. This includes monitoring for any adverse effects for up to 30 days post-injection.

Who Can Join the Study?

Patients must be older than 18 years if they have biopsy-proven HPV-negative head and neck squamous cell carcinoma (HNSCC), or older than 40 years if they have HPV-positive HNSCC with high-risk features (such as smoking more than 10 packs per year and having a certain level of lymph node involvement).
Patients should be planning to receive treatment with chemoradiotherapy using platinum-based chemotherapy.
Recent tumor tissue samples, taken less than 8 weeks before joining the study, should be available and have enough material left to check for PARP1 levels in the tumor.
The tumor must be at least 10 mm in diameter.
Patients should have an ECOG performance status of 0 to 2, which is a scale that measures how well a patient can perform daily activities.
Women who can have children must have a negative pregnancy test.
Patients should have a life expectancy of more than 3 months.
Patients must sign a written informed consent form and be able to follow the study protocol.
For Stage II of the study, a re-biopsy should be possible, as determined by the head-and-neck surgeon.

Who Cannot Join the Study?

Patients with any other type of cancer besides head and neck squamous cell carcinoma (HNSCC) cannot participate.
Patients who are pregnant or breastfeeding are not eligible.
Patients with severe medical conditions that could interfere with the study are excluded.
Patients who have participated in another clinical trial within the last 30 days are not allowed.
Patients with known allergies to the study drug or similar compounds cannot join the study.
Patients who are unable to comply with the study procedures and follow-up visits are not eligible.
Patients with a history of substance abuse that could affect their ability to participate are excluded.
Patients with certain heart conditions that could pose a risk during the study are not allowed.
Patients with active infections that require treatment are not eligible.
Patients who have had major surgery within the last 4 weeks are excluded.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Ugbxpuasothc Mxqtmnw Cfrxsyj Guzgvgass	Groningen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Not yet recruiting	01.02.2025

Trial locations

Investigated drugs:

Olaparib

[18F]-olaparib is a special type of imaging agent used in this clinical trial. It is designed to help doctors see how well a patient’s body is responding to treatment for DNA damage. This is done through a PET scan, which is a type of imaging test that shows how tissues and organs are functioning. In this trial, the goal is to find the best time to take these images and to ensure that using this imaging agent is safe for patients. Additionally, the trial aims to see if there is a connection between how much of this agent is taken up by the tumor and the levels of a specific protein called PARP-1 in the tumor tissue. This information can help doctors understand more about the tumor and how it might respond to certain treatments.

Investigated diseases:

Squamous cell carcinoma of head and neck

Head and neck squamous cell carcinoma (HNSCC) – This is a type of cancer that originates in the squamous cells lining the moist surfaces inside the head and neck, such as the mouth, nose, and throat. It typically begins as a flat, thin layer of cells and can develop into a tumor. As the disease progresses, the cancerous cells can invade deeper tissues and spread to other parts of the body, including lymph nodes. The progression of HNSCC can lead to symptoms such as a persistent sore throat, difficulty swallowing, and changes in voice. Over time, the tumor may grow larger and cause more noticeable symptoms, potentially affecting breathing and eating. The disease can vary in its rate of progression, depending on factors like the location of the tumor and the patient’s overall health.

Trial ID:

2024-511962-34-00

Protocol code:

19310

NCT ID:

NCT06482307

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study on Imaging Head and Neck Cancer Using [18F]-Olaparib for Patients with Squamous Cell Carcinoma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?