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AuthorisedPhase I and Phase II (Integrated)- First administration to humansInterventional

[18F]-olaparib PET; Molecular imaging of DNA damage response by [18F]-olaparib PET

This research is testing a new type of scan for head and neck cancer. It uses a special substance called [18F]-olaparib, which is designed to stick to certain proteins in cancer cells, making them show up on a PET scan. Doctors want to see how well this new scan works in people, especially how brightly cancer cells light up compared to healthy parts of the body. They will also check for any side effects. This early-stage study is a first step to see if this scanning technique could help improve how we find and treat head and neck cancers in the future. The overall goal is to find better ways to understand how these cancers grow and respond to treatment.

At a glance

Status
Authorised
Phase
Phase I and Phase II (Integrated)- First administration to humans
Sponsor
Universitair Medisch Centrum Groningen
Enrolment target
10
Start
22 Apr 2025

What is this study about?

This study is an early-stage research project looking into a new way to take pictures inside the body, specifically for a type of cancer called head and neck squamous cell carcinoma (HNSCC). This cancer affects areas like the mouth, throat, or voice box. The researchers are using a special substance called [18F]-olaparib, which is gently put into the body, to see if it can help them get clearer pictures of cancer cells using a type of scan called a PET scan. They want to find out how much of this substance goes into healthy organs and how much goes into the cancer itself, aiming for the cancer to show up more clearly than the surrounding healthy tissue.

The main goal is to understand if this new scanning technique can give doctors more information about head and neck cancers. They will be checking if the brightness of the cancer on the scan matches up with certain proteins (called PARP1) often found in these cancer cells. This could help doctors better understand how aggressive a tumour is. They will also carefully watch for any side effects from the substance.

Ultimately, if this scanning method works well, it could lead to better ways for doctors to spot head and neck cancers, understand their behaviour, and decide on the best treatment plans. It could also help assess how well treatments like chemotherapy and radiation are working in the future. This is an important step in developing more personalised and effective care for patients.

Key takeaways

  • This study is testing a new type of scan for head and neck cancer.
  • It uses a special substance to help cancer cells show up on a PET scan.
  • The aim is to see if this scan can provide more information about the cancer.
  • This is early-stage research, focusing on safety and how the scan works.
  • It may help develop better ways to detect and manage head and neck cancer in the future.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old. There's no upper age limit, meaning older adults can also take part. The study is open to both men and women.

Beyond age and sex, specific health conditions related to your head and neck cancer will be assessed by the study doctors to make sure this study is right for you and safe. This might include how advanced your cancer is and your general health condition.

Keep in mind that even if you meet these basic criteria, other medical tests and evaluations will be carried out to confirm your full eligibility.

Quick self-check
  • Are you 18 years old or older?
  • Do you have head and neck squamous cell carcinoma?
  • Are you able to attend appointments for imaging scans?
  • Are you able to understand the study and give your consent?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to join this study, you will receive a small, safe dose of a special substance called [18F]-olaparib in your bloodstream. This substance helps the doctors see certain things in your body using a type of scan called a PET scan. You will have a few PET scans done at different times after receiving the substance. The doctors will also carefully monitor you for any side effects for up to 30 days after you receive the substance.

In addition to the scans, the study might involve providing tissue samples (like a biopsy if you're already having one for your treatment) to check for specific proteins in your cancer cells. There may also be follow-up appointments, and if you are receiving treatment like chemoradiation as part of your standard care, you might have additional scans to see how your tumour changes. The total number of visits and exact duration will be explained by the study team.

Potential risks and benefits

Taking part in this study could potentially offer future benefits by helping to develop better ways to detect and treat head and neck cancer. While you may not directly benefit, the information gained could improve care for others. As with any medical procedure, there are potential risks, such as side effects from the [18F]-olaparib substance, though these are typically mild and carefully monitored. There's also a small amount of radiation exposure from the PET scans, similar to other medical imaging. You have the right to withdraw from the study at any time without explaining why, and your decision will not affect your usual medical care.

Locations (1)

  • Netherlands

Common questions

What is [18F]-olaparib?

It's a special, safe substance that helps doctors see cancer cells more clearly on a PET scan.

What are PET scans?

PET scans are a type of imaging test that helps doctors create detailed pictures of organs and tissues inside your body.

Will I receive any new treatment in this study?

No, this study is about a new type of imaging scan, not a new treatment. Your normal cancer treatment will continue as planned.

What are the possible side effects?

The study team will carefully monitor you for any side effects, which are usually mild, from the substance used in the scan. They will explain all known risks.

Can I stop participating if I change my mind?

Yes, you can choose to leave the study at any time, and your medical care will not be affected.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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