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Not yet recruiting NCT06482307

Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET

Phase I / Phase II Interventional Head and Neck Squamous Cell Carcinoma (HNSCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: [18F]-olaparib PET scan.
Who it may be relevant to
Registry conditions: Head and Neck Squamous Cell Carcinoma (HNSCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Diagnostic test [18F]-olaparib PET scan
    The IMP investigated is \[18F\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.

Primary outcome measures

  • Dosimetry assessment [Time frame: 6-12 months]
  • Correlation between tumour uptake and expression [Time frame: 12-18 months]
Secondary outcome measures (1)
  • Evaluation of changes in tumour uptake [Time frame: 12-18 months]

Eligibility criteria

Inclusion 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 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)

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Netherlands · 1 center
  • University Medical Center Groningen — Groningen

Identifiers

NCT: NCT06482307 · 19310

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗