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Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGPHASE1/PHASE2

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

NCT06482307•University Medical Center Groningen

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. 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)
•2. Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
•3. Recent archival tumour tissue (\<8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels
•4. Presence of a tumour lesion ≥10 mm in diameter
•5. ECOG performance status 0-2
•6. Negative pregnancy test in women with childbearing potential
•7. Life expectancy \>3 months
•8. Signed written informed consent and able to comply with the protocol
•9. For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)

Exclusion Criteria

•1. Recent treatment with PARP inhibitors or other investigational therapies \<30 days.
•2. Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.

Locations (1)

University Medical Center Groningen

Groningen, Netherlands

Key Dates

Start Date

May 1, 2025

Primary Completion Date

February 1, 2026

Completion Date

February 1, 2026

Last Updated

April 18, 2025

Enrollment

ESTIMATED participants

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Interventions

[18F]-olaparib PET scan

DIAGNOSTIC_TEST

Contacts

Michel van Kruchten, MD, PhD

CONTACT

+31 50 361 2821 m.van.kruchten@umcg.nl

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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