acromegaly, Cushing's disease, de novo or recurrence/persistence, Patients (male or female) ≥18 years old with Suspected functional pituitary adenoma (prolactinoma, thyrotropic adenoma), With indeterminate pituitary MRI.
Conditions
Brief summary
Prevalence of patients with positive 18FET PET, as determined by consensus among the three readers. PET positivity is defined as focal hyperuptake with an intensity greater than that of healthy cerebral and pituitary background signal.
Detailed description
Proportion of patients with a positive 18FET PET scan who received treatment targeting the adenoma (surgery and/or external beam radiation therapy) during the 12-month study period., Proportion of patients with a negative 18FET PET scan who underwent exploratory surgery during the 12-month study period., The proportion of patients who responded to surgery performed during the 12-month study period, as defined by an improvement or normalization of laboratory parameters in accordance with the recommendations specific to each histological subtype., SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain tissue and SUVmean in the adenoma to SUVmean in healthy brain tissue, as well as kinetic parameters (activity-time curve, time to peak) measured by 18FET PET., Evaluation of 18FET PET results by histological subtype (prevalence of patients with positive 18FET PET, SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain tissue and SUVmean in the adenoma to SUVmean in healthy brain tissue, as well as kinetic parameters [activity-time curve, time to peak] measured by 18FET PET)., Inter-reader agreement in the assessment of 18FET PET positivity, as measured by Krippendorff’s alpha coefficient.
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prevalence of patients with positive 18FET PET, as determined by consensus among the three readers. PET positivity is defined as focal hyperuptake with an intensity greater than that of healthy cerebral and pituitary background signal. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a positive 18FET PET scan who received treatment targeting the adenoma (surgery and/or external beam radiation therapy) during the 12-month study period., Proportion of patients with a negative 18FET PET scan who underwent exploratory surgery during the 12-month study period., The proportion of patients who responded to surgery performed during the 12-month study period, as defined by an improvement or normalization of laboratory parameters in accordance with the recommendations specific to each histological subtype., SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain tissue and SUVmean in the adenoma to SUVmean in healthy brain tissue, as well as kinetic parameters (activity-time curve, time to peak) measured by 18FET PET., Evaluation of 18FET PET results by histological subtype (prevalence of patients with positive 18FET PET, SUVmax, SUVmean, SUVpeak, the ratios of SUVmax in the adenoma to SUVmax in healthy brain | — |