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

NCT ID: NCT06482307

Last Updated: 2025-04-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-02-28

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.

Conditions

Head and Neck Squamous Cell Carcinoma (HNSCC)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stage I

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.

Group Type: EXPERIMENTAL

[18F]-olaparib PET scan

Intervention Type: DIAGNOSTIC_TEST

The IMP investigated is \[18F\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.

Stage II

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.

Group Type: EXPERIMENTAL

[18F]-olaparib PET scan

Intervention Type: DIAGNOSTIC_TEST

The IMP investigated is \[18F\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.

Interventions

[18F]-olaparib PET scan

The IMP investigated is \[18F\]Olaparib, a radiolabelled PARP inhibitor suitable for PET imaging.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel van Kruchten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Groningen

Locations

University Medical Center Groningen

Groningen, , Netherlands

Countries

Netherlands

Central Contacts

Michel van Kruchten, MD, PhD

Role: CONTACT

m.van.kruchten@umcg.nl

+31 50 361 2821

Facility Contacts

Michel van Kruchten, MD, PhD

Role: primary

m.van.kruchten@umcg.nl

+31 50 361 2821

Other Identifiers

19310

Identifier Type: -

Identifier Source: org_study_id