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NCT Number: NCT06482307

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC) Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location contact

Michel van Kruchten, MD, PhD

CONTACT

[email protected]

+31 50 361 2821

Michel van Kruchten, MD, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[18F]-olaparib PET scan

Diagnostic Test

The IMP investigated is [18F]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.

Primary outcomes

  1. Dosimetry assessment

    Time frame: 6-12 months

    Assess dosimetry, most optimal time point for imaging (Stage I), and safety of [18F]olaparib PET (Stage I + II)

  2. Correlation between tumour uptake and expression

    Time frame: 12-18 months

    Determine the correlation between tumour [18F]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).

Secondary outcomes

  1. Evaluation of changes in tumour uptake

    Time frame: 12-18 months

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Michel van Kruchten, MD, PhD

CONTACT

[email protected]

+31 50 361 2821

Sponsors and collaborators

Lead sponsor

University Medical Center Groningen

Other

Registry information

Acronym: [18F]-olaparib

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 1, 2024
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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