Health TrialsbyHealthPanel

FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease

ConditionsCushing DiseasePituitary Adenoma
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this research is to evaluate the performance \[sensitivity, specificity, accuracy\] of FET PET/CT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Biochemically diagnosed ACTH-dependent Cushing disease.

No previous pituitary surgery.

Planned to undergo pituitary surgery for localization/resection of adenoma.

No contraindications for PET/CT.

Disqualifiers

Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential

Declining to use effective contraceptive methods during the study (for individuals of child-bearing potential)

Need for emergent surgery that would be delayed by participation

Bacterial, viral, or fungal infections requiring systemic therapy

Trial design

Design model

Single group

Treatments tested in this trial

  • Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET

    Drug

    Patients will receive intravenous administration of radiolabeled FET (5mCi ±10%) administered 20 minutes (±10minutes) prior to the initiation of the attenuation correction CT followed by the PET acquisition encompassing the participant's head/neck, centered on the pituitary gland.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: (ACTH)-dependent Cushing diseaseExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of FET PET results in comparison to histopathology

Percentage of cases where surgical findings and pathology are in agreement with \[18F\]FET-PET/MRI imaging

Time frame
Baseline
2

Specificity of FET PET results in comparison to histopathology

Time frame
Baseline
3

Accuracy of FET PET results in comparison to histopathology

Time frame
Baseline

Secondary outcomes

1

Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR

Percentage of cases where pituitary protocol MR results are in agreement with FET-PET imaging

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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