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

ConditionHead and Neck Squamous Cell Carcinoma (HNSCC)
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Medical Center Groningen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Recent archival tumour tissue (<8 weeks prior to inclusion) should be available with suffi-cient residual material for determination of tumour PARP1 levels

Presence of a tumour lesion ≥10 mm in diameter

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • [18F]-olaparib PET scan

    Diagnostic test

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

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Stage IExperimental treatment 1 intervention
Group B: Stage IIExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dosimetry assessment

Assess dosimetry, most optimal time point for imaging (Stage I), and safety of \[18F\]olaparib PET (Stage I + II)

Time frame
6-12 months
2

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).

Time frame
12-18 months

Secondary outcomes

1

Evaluation of changes in tumour uptake

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).

Time frame
12-18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Medical Center Groningen

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: