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Imaging a Radioactive Tracer in Head and Neck Cancer Patients

Tests a radioactive scan that shows PARP proteins in head and neck cancer.

Plain-language title generated from the registry record
Registry title: Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET

Key facts

Where
Groningen, NetherlandsSee the site
Phase
Phase 1/2

Where in Netherlands

  • Universitair Medisch Centrum GroningenGroningen, NetherlandsNot yet recruiting

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Trial details

Who runs it
University Medical Center Groningen
Trial code
NCT06482307EU 2024-511962-34-00
Record updated
18 April 2025
Original description
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 full original descriptionShow less

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

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.

Inclusion: 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: 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.

ClinicalTrials.gov NCT06482307 · EU CTIS 2024-511962-34-00