Table 6.
Currently ongoing trials evaluating the role of positron emission tomography (PET)/CT in clinical practice
| ClinicalTrials.gov identifier | Study type | Study design | Clinical scenario | Purpose |
|---|---|---|---|---|
| NCT01179360 | Observational | Prospective | Treatment response assessment | To determine the performance of 18F-FDG-PET/CT with respect to detecting residual lymph node involvement after chemoradiation in order to omit planned neck dissections in patients with locally advanced potentially operable, N2 and N3 HNSCC |
| NCT02372890 | Observational | Prospective | Staging | To determine the sensitivity and specificity of lymph node staging with high-resolution 18F-FDG-PET/CT in HNSCC by correlating PET/CT with histopathology after neck dissection |
| NCT02047201 | Interventional | Prospective (safety/efficacy study) | Prognosis | To evaluate the safety and efficacy of cisplatin plus IMRT based on 18F-FDG-PET/CT after induction chemotherapy for locally advanced HNSCC. To evaluate correlation of OS, PFS and LRC with metabolic tumour response, anatomical tumour response, baseline SUV and HPV |
| NCT00606294 | Interventional | Prospective (non-randomized) | New tracers | To evaluate low oxygen areas called hypoxia within tumours in order to improve the accuracy of hypoxia imaging for head and neck cancers through pixel-by-pixel kinetic analysis of 18F-FMISO tracer of dynamic PET images |
| NCT01341535 | Interventional | Phase II randomized | Radiotherapy planning | To compare standard IMRT, using only pre-treatment planning 18F-FDG-PET/CT scans to adaptive (dose painting by numbers) 18F-FDG-PET-voxel intensity-based IMRT using repetitive per-treatment planning 18F-FDG-PET/CT to obtain increase in local control |
| NCT02273778 | Interventional | Pilot study | Radiotherapy planning | To investigate the use of co-registered 18F-FDG-PET-CT and MRI for radiotherapy planning in locally advanced HNSCC |
| NCT00147472 | Interventional | Prospective (non-randomized) | Residual disease | To determine the ability of PET to detect residual cancer in neck lymph nodes of patients following curative treatment with radiation therapy. Then, patients undergo neck dissection surgery (the PET and CT results are compared with the presence or absence of tumours in the neck nodes) |
| NCT01235052 | Interventional | Prospective | Treatment response assessment | Non-invasive assessment of hypoxia in cancer. Correlation between a hypoxic volume determined by 18F-FMISO PET-CT and a treatment response 2 years after radical treatment |
| NCT02262221 | Interventional | Randomized (Phase II) | Follow-up | To evaluate the cost effectiveness of two different follow-up programs in head and neck cancer survivors. ARM A (non-intensive follow-up) and ARM B (intervention foreseen is scheduled radiologic evaluations: CT or MRI scan and PET scan if patients ≥50 years old and with a smoking history of ≥20 packs per year) |
| NCT00954148 | Interventional | Randomized | Follow-up | To show that PET/CT will be superior (15% improvement) to conventional methods of follow-up in terms of 5-year survival, cost and time to identification of new disease |
| NCT00159978 | Observational | Prospective (Phase I) | New tracers | To validate 18F-FMISO-PET for detection of tumour hypoxia and 18F-FLT-PET for detection of tumour cell proliferation by immunohistochemical assessment of hypoxia and proliferation in head and neck cancer resection specimen |
18F-FDG-PET/CT, PET with fluorine-18 fludeoxyglucose integrated with CT; 18F-FLT, fluorine-18 fluorothymidine; 18F-FMISO, fluorine-18 fluoromisonidazole; HNSCC, head and neck squamous cell carcinoma; HPV, human papillomavirus; IMRT, intensity-modulated radiotherapy; LRC, locoregional control; OS, overall survival; PFS, progression-free survival; SUV, standardized uptake value.