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

NCT03346954 | Completed DMC

• 2 other identifiers: 69HCL17_01672017-002721-38
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for ACTH ectopic secretion. This rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal MRI image, if pituitary origin is confirmed by the catheterization. Although pituitary surgery without identified target is part of French recommendations, this surgery is associated with a high risk of failure and morbidity. Optimization of the management of patients' with Cushing's disease thus requires the improvement of the diagnostic methods. Hypothesis of our study is that \[11C\] MET MRI-PET may be performed as a first-line MRI for suspected Cushing's disease and may limit indications for catheterization of lower petrosal sinuses. Its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma

Conditions

Cushing's Disease

Keywords

: Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity

Outcome Measures

Primary Outcomes (1)

• Sensitivity of [11C]-Methionine PET/MRI

  Sensitivity of \[11C\]-Methionine PET/MRI to correctly localizes the pituitary corticotropic adenoma in comparison with the sensitivity of the pituitary MRI. The gold standard being the localization defined by anatomopathological analysis on operative resection.

  Within 3 months and 3 weeks after inclusion

Secondary Outcomes (3)

• False negatives and false positives description

  Within 3 months and 3 weeks after inclusion

• Description of identified microadenomas

  Within 3 months and 3 weeks months after inclusion

• Comparison of [11C]-Methionine PET/MRI and pituitary MRI

  Within 3 months and 3 weeks months after inclusion

Study Arms (1)

Patients with Cushing's disease

EXPERIMENTAL

Implementation of \[11C\]-Methionine PET/MRI

Other: [11C]-Methionine PET/MRI

Interventions

[11C]-Methionine PET/MRI OTHER

Implementation \[11C\]-Methionine PET/MRI performed for each patient in one place (department of nuclear medicine of the Hospices Civils de Lyon). The \[11C\]-Methionine PET/MRI will be performed after a pituitary MRI and before a transsphenoidal surgery.

Patients with Cushing's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Service de Médecine Nucléaire - Hospices Civils de Lyon

Bron, 69677, France

Location

Related Publications (1)

• Flaus A, Levigoureux E, Haesebaert J, Briet C, Castinetti F, Cristante J, Drui D, Germain N, Maione L, Illouz F, Sonnet E, Tauveron I, Merida I, Lancelot S, Costes N, Vasiljevic A, Marchand L, Rode S, Bertholon-Gregoire M, Criton G, Lapras V, Cotton F, Jouanneau E, Bournaud C, Raverot G. Prospective Multicenter Evaluation of [11C]Methionine PET/MRI Sensitivity Compared with MRI for Localizing Small Pituitary Neuroendocrine Tumor or Pituitary Adenoma in Cushing Disease. J Nucl Med. 2025 Oct 1;66(10):1575-1580. doi: 10.2967/jnumed.124.269392.

  PMID: 40841148 RESULT

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion; Hypersensitivity

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Immune System Diseases

Study Officials

• BOURNAUD Claire, MD

  Hospices Civils de Lyon

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 20, 2017
• Study Start: December 11, 2017
• Primary Completion: June 11, 2019
• Study Completion: August 31, 2020
• Last Updated: September 25, 2025

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)