A Phase 1/2 interventional study of [18F]-olaparib PET scan in Head and Neck Squamous Cell Carcinoma (HNSCC), sponsored by University Medical Center Groningen. Not yet recruiting at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-18.
Sponsored by University Medical Center Groningen · Phase 1/2, Interventional, and Diagnostic
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.
1,680 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 539 are open to participants now.
This study's planned enrollment of 10 is below the median of 49 across 1,432 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.
Browse Squamous Cell Carcinoma of Head and Neck studies →University Medical Center Groningen is the lead sponsor of 609 studies on the registry; 174 are open to participants now.
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Exclusion Criteria:
Five patients with HNSCC will undergo a dynamic \[18F\]-olaparib PET during 30 min, followed by a static whole body PET scans at 120 min post-injection of \[18F\]-olaparib.
Diagnostic Test: [18F]-olaparib PET scan
After determination of the most optimal time point for imaging, five patients with HNSCC scheduled for chemoradiotherapy will undergo serial \[18F\]-olaparib PET at baseline (i.e. prior to treatment initiation) and a second scan during the first week of chemoradiotherapy. Patients in stage II will undergo a study biopsy in the first week of chemoradiotherapy to evaluate changes in PARP protein expression.
Diagnostic Test: [18F]-olaparib PET scan
The IMP investigated is \[18F\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.
Dosimetry assessment
Assess dosimetry, most optimal time point for imaging (Stage I), and safety of \[18F\]olaparib PET (Stage I + II)
Time frame: 6-12 months
Correlation between tumour uptake and expression
Determine the correlation between tumour \[18F\]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II).
Time frame: 12-18 months
Evaluation of changes in tumour uptake
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).
Time frame: 12-18 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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University Medical Center Groningen