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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage I | Experimental | 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. |
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| Stage II | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [18F]-olaparib PET scan | Diagnostic Test | The IMP investigated is [18F]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging. |
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| Measure | Description | Time Frame |
|---|---|---|
| Dosimetry assessment | Assess dosimetry, most optimal time point for imaging (Stage I), and safety of [18F]olaparib PET (Stage I + II) | 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). | 12-18 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 12-18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michel van Kruchten, MD, PhD | Contact | +31 50 361 2821 | m.van.kruchten@umcg.nl |
| Name | Affiliation | Role |
|---|---|---|
| Michel van Kruchten, MD, PhD | University Medical Center Groningen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Medical Center Groningen | Groningen | 9713 GZ | Netherlands |
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| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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patients with HNSCC
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| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |