Cushing's DiseaseIMPECNCT03346954
Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
A study testing [11C]-Methionine PET/MRI in people with Cushing's Disease, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Disease
- What is being tested?
- [11C]-Methionine PET/MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 11 Dec 2017to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Nucléaire - Hospices Civils de Lyon
Bron, 69677
About this study
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
- Being tested
- [11C]-Methionine PET/MRI
- Keywords
- : Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity
- Medical subject headings
- Pituitary ACTH Hypersecretion, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[11C]-Methionine PET/MRIOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Cushing's disease | Experimental | Implementation of [11C]-Methionine PET/MRI Receives: Other: [11C]-Methionine PET/MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 3 months and 3 weeks after inclusion
Secondary outcomes (3)
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
Measured: Within 3 months and 3 weeks after inclusion
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.
Measured: Within 3 months and 3 weeks months after inclusion
Comparison of [11C]-Methionine PET/MRI and pituitary MRI
Study of the concordance between the results of [11C]-Methionine PET/MRI and pituitary MRI
Measured: Within 3 months and 3 weeks months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start11 Dec 2017
- Primary completion11 Jun 2019
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BOURNAUD Claire, MD, Study director, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346954
- Sponsor's protocol ID
- 69HCL17_0167
- Other IDs
- 2017-002721-38, 2017
- Acronym
- IMPEC
- Status last verified
- Nov 2020
- First submitted
- 15 Nov 2017
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40841148Flaus A, Pattee A, Criton G, Costes N, Levigoureux E, Haesebaert J, Vasiljevic A; IMPEC Collaborators; Jouanneau E, Cotton F, Bournaud C, Raverot G. [(1)(1)C]Methionine PET uptake kinetics in corticotroph pituitary neuroendocrine tumors. Sci Rep. 2026 Feb 27;16(1):8854. doi: 10.1038/s41598-026-39219-7.
PubMed 41760695
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
- ClinicalTrials.gov ID
- NCT03346954
- Acronym / sponsor ID
- IMPEC / 69HCL17_0167
- Conditions
- Cushing's Disease
- Keywords
- : Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 11 Dec 2017 (actual)
- Primary completion
- 11 Jun 2019 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Cushing's disease | Experimental | Other: [11C]-Methionine PET/MRIImplementation of [11C]-Methionine PET/MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- - 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| [11C]-Methionine PET/MRIImplementation [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. | Other | Patients with Cushing's disease |
Primary outcome
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.
3 secondary outcomes
False negatives and false positives description
Time frame: Within 3 months and 3 weeks after inclusion
Description of identified microadenomas
Time frame: Within 3 months and 3 weeks months after inclusion
Comparison of [11C]-Methionine PET/MRI and pituitary MRI
Time frame: Within 3 months and 3 weeks months after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Results publication: PubMed 40841148Flaus 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.
- Derived from this study: PubMed 41760695Flaus A, Pattee A, Criton G, Costes N, Levigoureux E, Haesebaert J, Vasiljevic A; IMPEC Collaborators; Jouanneau E, Cotton F, Bournaud C, Raverot G. [(1)(1)C]Methionine PET uptake kinetics in corticotroph pituitary neuroendocrine tumors. Sci Rep. 2026 Feb 27;16(1):8854. doi: 10.1038/s41598-026-39219-7.
- Individual participant dataSharing planned: No
Related trials for Cushing's Disease
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 1/2
Diagnostic Value of CXCR4-targeted PET/CT in ACTH-dependent and Independent Cushing's Syndrome
Cushing s Syndrome
RecruitingObservational study
Long-Term Follow-Up of Survivors of Pediatric Cushing Disease
Cushing Disease
RecruitingPhase 4
Osilodrostat in Patients With Hypertension Caused by Hypercortisolaemia Due to Cushing's Syndrome
Hypertension, Hypercortisolemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BOURNAUD Claire, MD study director
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [11C]-Methionine PET/MRI in people with Cushing's Disease, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity of [11C]-Methionine PET/MRI (time frame: Within 3 months and 3 weeks after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03346954, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.