Not yet recruiting

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

Verified siteInvestigationalNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

9 criteria

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 trial?

10 criteria

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.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Universitair Medisch Centrum Groningen
Groningen, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

[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.

Olaparib

What is already known about the treatment

[18F]-olaparib – This medication is administered as a PET imaging agent, which means it is used in a special type of scan to help visualize certain processes in the body. Currently, it is being studied in clinical trials to understand its effectiveness and safety in imaging DNA damage response in patients with head and neck squamous cell carcinoma (HNSCC). The main purpose of this medication is to help doctors see how much of a protein called PARP-1 is present in tumors, which can be important for understanding the cancer better. At the molecular level, [18F]-olaparib works by binding to PARP-1, allowing it to be seen on PET scans. It is classified as a radiopharmaceutical, which is a type of drug used in nuclear medicine for imaging.

Investigated diseases

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.