Clinical trial: Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease (NCT03346954)

Eligibility criteria:
Inclusion Criteria:

          -  Aged 18 years old or over

          -  Patient with a diagnosed Cushing's disease according to the French "protocole national
             de diagnostic et de soins (PNDS)"

          -  Patient who underwent a MRI pituitary for diagnostic purposes

          -  Patient who have undergone catheterization of the lower petrosal sinuses (if MRI does
             not detect pituitary adenoma) and have a result in favor of a central secretion of
             ACTH

          -  Patient having an indication of surgical excision of the adenoma

          -  Patient with a micro-adenoma (less than 1 cm in diameter) if the tumor is visualized
             on MRI

          -  Patient for which informed and written consent to participate has been obtained.

        Exclusion Criteria:

          -  - Patient participating in another study

          -  Patient with a pituitary macro-adenoma with visual impairment

          -  Patient with ACTH-dependent Cushing's syndrome secondary to ectopic ACTH secretion

          -  Patient with recurrence and / or history of pituitary adenoma excision

          -  Patient with a contraindication to pituitary surgery or general anesthesia

          -  Pregnant woman, breastfeeding or old enough to have children but without effective
             recognized contraception

          -  Contra-indication to the realization of an MRI: permanently fixed metal parts
             (pacemaker, cerebral clip, cephalic end piercing, cochlear implant, pin or screw for
             recent bone fracture, dental equipment, metal splinters), claustrophobia
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 47-year-old man comes to the office due to weight gain and fatigue.  He is not able to lift heavy objects or climb stairs. Family history is positive for DM type 2 and HTN in his father.  Blood pressure is 165/90 mm Hg and pulse is 85/min.  On physical examination, there is symmetric proximal muscle weakness of the upper and lower extremities.  Fasting plasma glucose level is 138 mg/dL and 24-hour urinary cortisol is twice the upper normal limit.  Further evaluation reveals that high-dose, but not low-dose, dexamethasone suppresses serum cortisol levels.  Serum ACTH levels are high-normal. This patient's findings are consistent with endogenous Cushing Syndrome.

Patient description (patient's own words): I'm a 47-year-old man. I went to the clinic because I had been gaining weight and had increased fatigue over the past few weeks. I was not able to lift heavy objects or even climb the stairs. My dad was diagnosed with type 2 diabetes and high blood pressure. During the exam, they took my blood pressure, which was 165/90 mm Hg, and my pulse was 85/min. They found out that I have weaknesses in both of my arms and legs. I also did a blood test on an empty stomach, and I had a glucose level of 138 mg/dL, and twice the upper normal limit of cortisol. I had high-normal levels of ACTH. The doctor said I suffer from endogenous Cushing Syndrome.

Does the patient match the trial criteria? Contradiction