None listed
Conditions
Brief summary
This study is an observational study investigating the use of new tracer for Positron Emission Tomography (PET). This tracer is preferentially taken up by cells that undergo rapid proliferation. The study has two aims: to assess the feasibility of conducting a larger trial, and to assess the sensitivity and specificity of FLT PET. The target patient population is those with locoregionally advanced mucosal head and neck squamous cell carcinoma undergoing definitive chemoradiation. You may be eligible to join this study if you are aged 18 and over, and have a previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx - Stage III or IV (TNM staging). You must be suitable for definitive radiotherapy + concurrent systemic treatment. Further details on the inclusion criteria for this study can be found in the relevant section on this form. Trial details All participants in this trial will undergo their standard cancer treatment, but with the addition of 2 18Fluoro-L-Thymidine and Positron Emission Tomography (FLT-PET) scans at baseline and at week 3 of radiotherapy. This will involve injection of FLT (study tracer) with scan commencing 60 minutes later.
Interventions
18-Fluoro-L-Thymidine (FLT)
FLT is administerd for Positron Emission Tomography (PET) for staging of mucosal head and neck cancer. We aim to compare FLT-PET staging with F-2-fluoro-2-deoxy-D-glucose (FDG) PET which is the current best non-surgical staging modality.
FLT is preferentially taken up by cells that undergo rapid proliferation. FDG is the standard tracer and is taken up by cells that utilise glucose. Cancer cells are rapidly dividing cells.
FLT is given via an injection, 60 minutes la
18-Fluoro-L-Thymidine (FLT) FLT is administerd for Positron Emission Tomography (PET) for staging of mucosal head and neck cancer. We aim to compare FLT-PET staging with F-2-fluoro-2-deoxy-D-glucose (FDG) PET which is the current best non-surgical staging modality. FLT is preferentially taken up by cells that undergo rapid proliferation. FDG is the standard tracer and is taken up by cells that utilise glucose. Cancer cells are rapidly dividing cells. FLT is given via an injection, 60 minutes later the scan is commenced. A total of 2 FLT PET scans are performed. 1 at baseline, the other at radiotherapy week 3. Patients will be observed for a total of 5 years.
Sponsors
Royal Brisbane and Women's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Previously untreated biopsy proven mucosal head and neck Squamous Cell Carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx - Stage III or IV - suitable for definitive radiotherapy + concurrent systemic treatment. - Adequate biopsy samples for EGFR and Ki-67 analyses - Age >=18 - ECOG performance status <=2 - Absolute neutrophil count >=1.5 x 109/L, platelet count >=100 x 109/L, and hemoglobin >=9 g/dL - Serum Bilirubin <1.25 times Upper Limit of Normal Range (ULN) and AST/ALT <=2.5 times ULN. Calculated creatinine clearance (Cockcroft-Gault) >=55 ml/min - Signed informed consent - Available for follow up for a minimum of 2 years after treatment - Life expectancy greater than 6 months
Exclusion criteria
- Nasopharyngeal carcinoma - Paranasal cavity tumours - Any suggestion of metastases on conventional CT scan and/or FDG-PET images - History of previous malignancy- excluding superficial Basal Cell Carcinoma and Squamous Cell Carcinoma - Other synchronous malignancies - Pregnant or lactating women - Previous radiotherapy to the head and neck region - High risk for poor compliance with therapy or follow-up as assessed by investigator - Unable to undergo PET studies
Outcome results
None listed