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

University Medical Center Groningen (UMCG)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Head and Neck Squamous Cell Carcinoma (HNSCC)

Treatments: Diagnostic Test: [18F]-olaparib PET scan

Study type: Interventional

Funder types: Other

Identifiers

NCT06482307

19310

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Stage I

Experimental group

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.

Treatment:

Diagnostic Test: [18F]-olaparib PET scan

Stage II

Experimental group

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.

Treatment:

Diagnostic Test: [18F]-olaparib PET scan