NCT03346954: IMPEC

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

Completed NA Last updated 25 September 2025

What this trial tests

NA trial testing [11C]-Methionine PET/MRI in Cushing's Disease in 33 participants. Completed in 31 August 2020.

Timeline

11 December 2017

Primary endpoint
11 June 2019

31 August 2020

Quick facts

Lead sponsor	Hospices Civils de Lyon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	33
Start date	11 December 2017
Primary completion	11 June 2019
Estimated completion	31 August 2020
Sites	1 location across France

Drugs / interventions tested

• [11C]-Methionine PET/MRI

Conditions studied

• Cushing's Disease — all drugs for Cushing's Disease →

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Cushing's Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prospective Multicenter Evaluation of [<sup>11</sup>C]Methionine PET/MRI Sensitivity Compared with MRI for Localizing Small Pituitary Neuroendocrine Tumor or Pituitary Adenoma in Cushing Disease.
   Flaus A, Levigoureux E, Haesebaert J, Briet C, et al · · 2025 · cited 5× · PMID 40841148 · DOI 10.2967/jnumed.124.269392
2. The Role of Standard and Advanced Imaging for the Management of Brain Malignancies From a Radiation Oncology Standpoint.
   Press RH, Zhong J, Gurbani SS, Weinberg BD, et al · · 2019 · cited 5× · PMID 30535032 · DOI 10.1093/neuros/nyy461
3. [¹¹C]Methionine PET uptake kinetics in corticotroph pituitary neuroendocrine tumors.
   Flaus A, Pattée A, Criton G, Costes N, et al · · 2026 · PMID 41760695 · DOI 10.1038/s41598-026-39219-7