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

Primary Purpose

Cushing's Disease

Status

Completed

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

[11C]-Methionine PET/MRI

About this trial

This is an interventional diagnostic trial for Cushing's Disease focused on measuring : Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Service de Médecine Nucléaire - Hospices Civils de Lyon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with Cushing's disease

Arm Description

Implementation of [11C]-Methionine PET/MRI

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

False negatives and false positives description

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

Description of identified microadenomas

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.

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

Study of the concordance between the results of [11C]-Methionine PET/MRI and pituitary MRI

Full Information

NCT ID

NCT03346954

First Posted

November 15, 2017

Last Updated

November 30, 2020

Sponsor

Hospices Civils de Lyon

1. Study Identification

Unique Protocol Identification Number

NCT03346954

Brief Title

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

Acronym

IMPEC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2020

Overall Recruitment Status

Completed

Study Start Date

December 11, 2017 (Actual)

Primary Completion Date

June 11, 2019 (Actual)

Study Completion Date

August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cushing's Disease

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Patients with Cushing's disease

Arm Type

Experimental

Arm Description

Implementation of [11C]-Methionine PET/MRI

Intervention Type

Other

Intervention Name(s)

[11C]-Methionine PET/MRI

Intervention Description

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 Measure Information:

Title

Sensitivity of [11C]-Methionine PET/MRI

Description

Time Frame

Within 3 months and 3 weeks after inclusion

Secondary Outcome Measure Information:

Title

False negatives and false positives description

Description

Time Frame

Within 3 months and 3 weeks after inclusion

Title

Description of identified microadenomas

Description

Time Frame

Within 3 months and 3 weeks months after inclusion

Title

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

Description

Study of the concordance between the results of [11C]-Methionine PET/MRI and pituitary MRI

Time Frame

Within 3 months and 3 weeks months after inclusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

BOURNAUD Claire, MD

Organizational Affiliation

Hospices Civils de Lyon

Official's Role

Study Director

Facility Information:

Facility Name

Service de Médecine Nucléaire - Hospices Civils de Lyon

City

Bron

ZIP/Postal Code

69677

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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