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Trial Title:
Molecular Imaging of DNA Damage Response by [18F]-Olaparib PET
NCT ID:
NCT06482307
Condition:
Head and Neck Squamous Cell Carcinoma (HNSCC)
Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck
Olaparib
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Intervention model description:
patients with HNSCC
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
[18F]-olaparib PET scan
Description:
The IMP investigated is [18F]Olaparib, a radiolabelled PARP inhibitor suitable for PET
imaging.
Arm group label:
Stage I
Arm group label:
Stage II
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University Medical Center Groningen
Address:
City:
Groningen
Zip:
9713 GZ
Country:
Netherlands
Contact:
Last name:
Michel van Kruchten, MD, PhD
Phone:
+31 50 361 2821
Email:
m.van.kruchten@umcg.nl
Investigator:
Last name:
Michel van Kruchten, MD, PhD
Email:
Principal Investigator
Start date:
October 2024
Completion date:
October 2025
Lead sponsor:
Agency:
University Medical Center Groningen
Agency class:
Other
Source:
University Medical Center Groningen
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06482307
