Skip to content

18F-fluoro-ethyl-tyrosine (18FET) PET for difficult clinical situations in functional pituitary adenoma. A prospective, single arm, single center study. (FET-PIT)

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-523829-17-00
Enrollment
30
Registered
2026-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

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

DRUGIASOglio 2 GBq/mL
DRUGsolution injectable

Sponsors

Centre Hospitalier Universitaire De Lille
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: EU CTIS · Data processed: Jul 3, 2026