NCT06482307Not yet recruitingPhase 1/2
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
Source: ClinicalTrials.gov · Last updated 18 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
This is a single-centre, non-randomized, two-stage design, proof-of-concept study evaluating the radiolabelled PARP inhibitor \[18F\]-olaparib als potential tracer for imaging of tumour PARP expression by PET.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 25 Jun 2024
- Start date
- May 2025
- Primary completion date
- Feb 2026
- Lead sponsor
- University Medical Center Groningen
- Diseases
- Head and neck cancer
- NCT number
- NCT06482307
- EU CT number
- 2024-511962-34-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 10
- From May 2025 to the primary completion date, Feb 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Recent treatment with PARP inhibitors or other investigational therapies \<30 days.
Other
- Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.
Who the study is looking for
- 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 suffi-cient 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 (assessed by head-and-neck surgeon)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen Coordinator of this site? Confirm its status | Groningen | Netherlands | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.