Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET

Phase 1

Not yet recruiting

• Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)
• Interventions: Diagnostic Test: [18F]-olaparib PET scan

• Registration Number: NCT06482307
• Lead Sponsor: University Medical Center Groningen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-25
• Study First Submitted QC: 2024-06-25
• Study First Posted: 2024-07-01
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2026-02
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stage I	[18F]-olaparib PET scan	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.
Stage II	[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.

Primary Outcome Measures

Name	Time	Method
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).
Dosimetry assessment	6-12 months	Assess dosimetry, most optimal time point for imaging (Stage I), and safety of \[18F\]olaparib PET (Stage I + II)

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands