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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 January 2021
• Main ID: NCT03346954
• Date of registration: 15/11/2017
• Prospective Registration: Yes
• Primary sponsor: Hospices Civils de Lyon
• Public title: Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease IMPEC
• Scientific title: Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
• Date of first enrolment: December 11, 2017
• Target sample size: 33
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03346954
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: BOURNAUD Claire, MD
• Affiliation: Hospices Civils de Lyon

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Cushing's Disease

Intervention(s)

Other: [11C]-Methionine PET/MRI

Primary Outcome(s)

Sensitivity of [11C]-Methionine PET/MRI [Time Frame: Within 3 months and 3 weeks after inclusion]

Secondary Outcome(s)

Comparison of [11C]-Methionine PET/MRI and pituitary MRI [Time Frame: Within 3 months and 3 weeks months after inclusion]

Description of identified microadenomas [Time Frame: Within 3 months and 3 weeks months after inclusion]

False negatives and false positives description [Time Frame: Within 3 months and 3 weeks after inclusion]

Secondary ID(s)

2017-002721-38

69HCL17_0167

Source(s) of Monetary Support

Please refer to primary and secondary sponsors