Head and Neck Squamous Cell Carcinoma (HNSCC)Phase 1/2[18F]-olaparibNCT06482307
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
A Phase 1/2 study testing [18F]-olaparib PET scan in people with Head and Neck Squamous Cell Carcinoma (HNSCC), run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma (HNSCC)
- What is being tested?
- [18F]-olaparib PET scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2025to Feb 2026
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site
University Medical Center Groningen
Groningen, 9713 GZ
Michel van Kruchten, MD, PhD, +31 50 361 2821, m.van.kruchten@umcg.nl
Michel van Kruchten, MD, PhD
About this study
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.
- Being tested
- [18F]-olaparib PET scan
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]-olaparib PET scanDiagnostic test
The IMP investigated is [18F]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Stage I | Experimental | Five patients with HNSCC will undergo a dynamic [18F]-olaparib PET during 30 min, followed by a static whole body PET scans at 120 min post-injection of [18F]-olaparib. Receives: Diagnostic Test: [18F]-olaparib PET scan |
| Stage II | Experimental | After determination of the most optimal time point for imaging, five patients with HNSCC scheduled for chemoradiotherapy will undergo serial [18F]-olaparib PET at baseline (i.e. prior to treatment initiation) and a second scan during the first week of chemoradiotherapy. Patients in stage II will undergo a study biopsy in the first week of chemoradiotherapy to evaluate changes in PARP protein expression. Receives: Diagnostic Test: [18F]-olaparib PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetry assessment
Assess dosimetry, most optimal time point for imaging (Stage I), and safety of [18F]olaparib PET (Stage I + II)
Measured: 6-12 months
Correlation between tumour uptake and expression
Determine the correlation between tumour [18F]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).
Measured: 12-18 months
Secondary outcomes (1)
Evaluation of changes in tumour uptake
Evaluate changes in tumour [18F]-olaparib uptake, as a read-out of DNA damage, during treatment with platinum-based chemoradio-therapy, and its correlation with changes in PARP protein expression (Stage II).
Measured: 12-18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study startMay 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionFeb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell Carcinoma (HNSCC)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- patients with HNSCC
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel van Kruchten, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06482307
- Sponsor's protocol ID
- 19310
- Acronym
- [18F]-olaparib
- Status last verified
- Apr 2025
- First submitted
- 25 Jun 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided