Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions
Brief 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.
Interventions
DIAGNOSTIC_TEST[18F]-olaparib PET scan
The IMP investigated is \[18F\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.
Sponsors
University Medical Center Groningen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
patients with HNSCC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dosimetry assessment | 6-12 months | Assess dosimetry, most optimal time point for imaging (Stage I), and safety of \[18F\]olaparib PET (Stage I + II) |
| Correlation between tumour uptake and expression | 12-18 months | Determine the correlation between tumour \[18F\]-olaparib uptake and tumour PARP-1 expression levels on tumour biopsy (Stage I + II). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of changes in tumour uptake | 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). |
Countries
Netherlands
Contacts
Primary ContactMichel van Kruchten, MD, PhD
Outcome results
None listed