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

NCT06482307 | Not Yet Recruiting Phase 1

• 1 other identifier: 19310
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Evaluation of changes in tumour uptake

  12-18 months

Study Arms (2)

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.

Diagnostic Test: [18F]-olaparib PET scan

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.

Diagnostic Test: [18F]-olaparib PET scan

Interventions

[18F]-olaparib PET scan DIAGNOSTIC_TEST

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

Stage I; Stage II

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• Treatment with chemoradiotherapy using platinum-based chemotherapy is anticipated
• Presence of a tumour lesion ≥10 mm in diameter
• ECOG performance status 0-2
• Negative pregnancy test in women with childbearing potential
• Life expectancy \>3 months
• Signed written informed consent and able to comply with the protocol
• For stage II only: re-biopsy should be deemed feasible by the investigators (assessed by head-and-neck surgeon)

You may not qualify if:

• Recent treatment with PARP inhibitors or other investigational therapies \<30 days.
• Presence of significant co-morbidities that make participation in the study undesirable according to the treating physician.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Officials

• Michel van Kruchten, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michel van Kruchten, MD, PhD

CONTACT

+31 50 361 2821; m.van.kruchten@umcg.nl

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: patients with HNSCC

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: May 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-04

Locations

NL (1)