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[18F]-olaparib PET; Molecular imaging of DNA damage response by [18F]-olaparib PET
EU CTIS ID: 2024-511962-34-00
What this study is testing
To assess dosimetry, most optimal time point for imaging (Stage I), and safety of [18F]olaparib PET (Stage I + II). To determine the correlation between tu-mour [18F]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients >18y, with biopsy-proven HPV-negative HNSCC, or patients >40y with HPV-positive HNSCC and high-risk features (i.e. > 10 smoke packs/year AND ≥N2b)
- Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
- Recent archival tumour tissue (<8 weeks prior to inclusion) should be available with sufficient residual material for determination of tumour PARP1 levels
- Presence of a tumour lesion ≥10 mm in diameter
- ECOG performance status 0-2
- Negative pregnancy test in women with childbearing potential
You likely can't join if
- Recent treatment with PARP inhibitors or other investigational therapies <30 days.
- Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.
See the full eligibility criteria
- Patients >18y, with biopsy-proven HPV-negative HNSCC, or patients >40y with HPV-positive HNSCC and high-risk features (i.e. > 10 smoke packs/year AND ≥N2b)
- Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
- Recent archival tumour tissue (<8 weeks prior to inclusion) should be available with sufficient residual material for determination of tumour PARP1 levels
- Presence of a tumour lesion ≥10 mm in diameter
- ECOG performance status 0-2
- Negative pregnancy test in women with childbearing potential
- Life expectancy >3 months
- Signed written informed consent and able to comply with the protocol
- For stage II only: re-biopsy should be deemed feasible by the investigators (as-sessed by head-and-neck surgeon)
- Recent treatment with PARP inhibitors or other investigational therapies <30 days.
- Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.