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Trial record 23 of 40 for:    Recruiting, Not yet recruiting, Available Studies | "Hospice Care"

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

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ClinicalTrials.gov Identifier: NCT03346954
Recruitment Status : Not yet recruiting
First Posted : November 20, 2017
Last Update Posted : November 21, 2017
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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


Condition or disease Intervention/treatment Phase
Cushing's Disease Other: [11C]-Methionine PET/MRI Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : April 1, 2018
Estimated Study Completion Date : January 1, 2019


Arm Intervention/treatment
Experimental: Patients with Cushing's disease
Implementation of [11C]-Methionine PET/MRI
Other: [11C]-Methionine PET/MRI
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.




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


Secondary Outcome Measures :
  1. False negatives and false positives description [ Time Frame: Within 3 months and 3 weeks after inclusion ]
    Description of false negatives and false positives [11C]-Methionine PET/MRI to identify and localize the microadenoma. Characteristics of unidentified adenomas will be described using: volume, localization, type of fixation

  2. Description of identified microadenomas [ Time Frame: Within 3 months and 3 weeks months after inclusion ]
    Proportion of microadenomas identified by the [11C]-Methionine PET/MRI as a function of the degree of aggressiveness of the adenoma, evaluated by the number of mitoses, the level of expression of Ki67 and p53.

  3. Comparison of [11C]-Methionine PET/MRI and pituitary MRI [ Time Frame: Within 3 months and 3 weeks months after inclusion ]
    Study of the concordance between the results of [11C]-Methionine PET/MRI and pituitary MRI



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346954


Contacts
Contact: BOURNAUD Claire, MD +33 4 27 35 72 81 claire.bournaud@chu-lyon.fr
Contact: LEVIGOUREUX Elise, PharmD +33 4 27 85 54 72 elise.levigoureux@chu-lyon.fr

Locations
France
Service de Médecine Nucléaire - Hospices Civils de Lyon Not yet recruiting
Bron, France, 69677
Contact: BOURNAUD claire, MD    +33 4 27 35 72 81    claire.bournaud@chu-lyon.fr   
Contact: LEVIGOUREUX Elise, PharmD    +33 4 27 85 54 72    elise.levigoureux@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Study Director: BOURNAUD Claire, MD Hospices Civils de Lyon

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03346954     History of Changes
Other Study ID Numbers: 69HCL17_0167
First Posted: November 20, 2017    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospices Civils de Lyon:
: Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity

Additional relevant MeSH terms:
Adenoma
Pituitary Neoplasms
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Hypothalamic Neoplasms
Supratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hypothalamic Diseases
Pituitary Diseases
Endocrine System Diseases
Hyperpituitarism