Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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 design
Treatments tested in this trial
- [18F]-olaparib PET scan
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov