Clinical trial · Interventional
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
NCT06482307CI-TRIAL-00088706[18F]-olaparibnot yet recruitingPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma (HNSCC) | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| [18F]-olaparib PET scan | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stage I
- description
- 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.
- interventionNames
- Diagnostic Test: [18F]-olaparib PET scan
- type
- EXPERIMENTAL
- label
- Stage II
- description
- 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.
- interventionNames
- Diagnostic Test: [18F]-olaparib PET scan
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.