Pituitary AdenomaNCT03714763
Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)
A study testing Drug treatment and Surgery in people with Pituitary Adenoma, run by Zhebao Wu.
Trial summary
To study the in vivo expression of dopamine D2 receptors in nonfunctioning pituitary adenoma and the predictive role of dopamine dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists（DA）. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pituitary Adenoma
- What is being tested?
- Drug treatment and Surgery
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2018to 31 Jan 2022
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Normal serum pituitary hormone levels or mild increase of serum prolactin.
- Enhanced MRI shows a pituitary tumor and tumor diameter>1cm.
- Aged between 18 and 65 years old, either sex.
- Karnofsky performance status ≥ 70.
- The patient has signed the informed consent.
Who cannot join
- Patients concomitantly taking the psychotropic drugs.
- Patients with parkinson disease and is taking dopaminergic agents.
- Patients with pituitary adenoma who received Gamma knife treatment.
- Pregnant or lactating women.
- Patients with poor compliance, who cannot implement the program strictly.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
- Patients with claustrophobia. -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
To study the in vivo expression of dopamine D2 receptors in nonfunctioning pituitary adenoma and the predictive role of dopamine dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists（DA）.
Read the detailed description
Dopamine agonists are the first line therapy for prolactinoma,which are also effective in some cases of other subtypes of pituitary tumors. It had been showed that dopamine agonists inhibit prolactin secretion by binding to and activating dopamine D2 receptors. PET-MR combined MR images with PET function images is substantial to evaluate the expression of dopamine D2 receptors.The aim is to study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.
- Conditions
- Pituitary Adenoma
- Being tested
- Drug treatment, Surgery
- Keywords
- Nonfunctioning Pituitary Adenoma, Dopamine Agonist, Dopamine D2 Receptors, PET-MR
- Medical subject headings
- Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug treatmentDrug
Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The medication will be stopped if failure to decrease tumor size and the subjects will be advised to surgical therapy.
SurgeryOther
Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .
| Study group | Role | What they receive |
|---|---|---|
| Drug treatment | Experimental | Subjects who show high expression of dopamine D2 receptors in PET-MR imaging. Receives: Drug: Drug treatment |
| Surgery | Experimental | Subjects who show low expression of dopamine D2 receptors in PET-MR imaging. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on tumor volume
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）.
Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visit.
Measured: Up to 6 months]
Secondary outcomes (2)
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit.
Measured: Up to 6 months
Change from visual field scale
2.Record the Visual field scale on every 3 month follow-up visit, 0 = normal, no vision loss; 1 = one quadrant vision loss; 2 = two quadrants of vision loss; 3 = three quadrants of vision loss; 4 = four quadrants of vision loss but retain a central tubular vision; 5 = blind
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Nov 2018 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion31 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhebao Wu
- Sponsor type
- University, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, First Hospital of China Medical University, Beijing Tiantan Hospital, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Fujian Medical University, Peking Union Medical College Hospital, Huashan Hospital, Chinese PLA General Hospital
- Responsible party
- Sponsor-investigator, Zhebao Wu, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714763
- Sponsor's protocol ID
- DD2RN-2018
- Status last verified
- Oct 2018
- First submitted
- 14 Oct 2018
- Last updated
- 22 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.
Publications
Mukherjee J, Majji D, Kaur J, Constantinescu CC, Narayanan TK, Shi B, Nour MT, Pan ML. PET radiotracer development for imaging high-affinity state of dopamine D2 and D3 receptors: Binding studies of fluorine-18 labeled aminotetralins in rodents. Synapse. 2017 Mar;71(3):10.1002/syn.21950. doi: 10.1002/syn.21950. Epub 2016 Nov 30.
PubMed 27864853Cooper O, Melmed S. Subclinical hyperfunctioning pituitary adenomas: the silent tumors. Best Pract Res Clin Endocrinol Metab. 2012 Aug;26(4):447-60. doi: 10.1016/j.beem.2012.01.002. Epub 2012 May 22.
PubMed 22863387Colao A, Di Somma C, Pivonello R, Faggiano A, Lombardi G, Savastano S. Medical therapy for clinically non-functioning pituitary adenomas. Endocr Relat Cancer. 2008 Dec;15(4):905-15. doi: 10.1677/ERC-08-0181. Epub 2008 Sep 9.
PubMed 18780796Su Z, Wang C, Wu J, Jiang X, Chen Y, Chen Y, Zheng W, Zhuge Q, Wu Z, Zeng Y. Expression of dopamine 2 receptor subtype mRNA in clinically nonfunctioning pituitary adenomas. Neurol Sci. 2012 Apr;33(2):275-9. doi: 10.1007/s10072-011-0701-6. Epub 2011 Jul 12.
PubMed 21748460
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma
- ClinicalTrials.gov ID
- NCT03714763
- Acronym / sponsor ID
- DD2RN-2018
- Conditions
- Pituitary Adenoma
- Keywords
- Nonfunctioning Pituitary Adenoma, Dopamine Agonist, Dopamine D2 Receptors, PET-MR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zhebao WuUniversity, hospital or other
- Collaborators
- Xinqiao Hospital of Chongqing, First Hospital of China Medical University, Beijing Tiantan Hospital, First Affiliated Hospital of Wenzhou Medical University, First Affiliated Hospital of Fujian Medical University, Peking Union Medical College Hospital, Huashan Hospital, Chinese PLA General Hospital
- Study start
- 1 Nov 2018 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 22 Oct 2018 (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.
To study the in vivo expression of dopamine D2 receptors in nonfunctioning pituitary adenoma and the predictive role of dopamine dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists（DA）.
Detailed description
Dopamine agonists are the first line therapy for prolactinoma,which are also effective in some cases of other subtypes of pituitary tumors. It had been showed that dopamine agonists inhibit prolactin secretion by binding to and activating dopamine D2 receptors. PET-MR combined MR images with PET function images is substantial to evaluate the expression of dopamine D2 receptors.The aim is to study the in vivo expression of dopamine D2 receptors in prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug treatment | Experimental | Drug: Drug treatmentSubjects who show high expression of dopamine D2 receptors in PET-MR imaging. |
| Surgery | Experimental | Other: SurgerySubjects who show low expression of dopamine D2 receptors in PET-MR imaging. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Normal serum pituitary hormone levels or mild increase of serum prolactin.
- Enhanced MRI shows a pituitary tumor and tumor diameter>1cm.
- Aged between 18 and 65 years old, either sex.
- Karnofsky performance status ≥ 70.
- The patient has signed the informed consent.
Key exclusion criteria (7 listed)
- Patients concomitantly taking the psychotropic drugs.
- Patients with parkinson disease and is taking dopaminergic agents.
- Patients with pituitary adenoma who received Gamma knife treatment.
- Pregnant or lactating women.
- Patients with poor compliance, who cannot implement the program strictly.
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 |
|---|---|---|
| Drug treatmentSubjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The medication will be stopped if failure to decrease tumor size and the subjects will be advised to surgical therapy. | Drug | Drug treatment |
| SurgerySubjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery . | Other | Surgery |
Primary outcome
Change from baseline on tumor volume
Time frame: Up to 6 months]
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）. Record the tumor volume from enhanced pituitary MRI on every 3 month follow-up visit.
2 secondary outcomes
Change from baseline of visual acuity
Time frame: Up to 6 months
Change from visual field scale
Time frame: Up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2018.
- Results publication: PubMed 27864853Mukherjee J, Majji D, Kaur J, Constantinescu CC, Narayanan TK, Shi B, Nour MT, Pan ML. PET radiotracer development for imaging high-affinity state of dopamine D2 and D3 receptors: Binding studies of fluorine-18 labeled aminotetralins in rodents. Synapse. 2017 Mar;71(3):10.1002/syn.21950. doi: 10.1002/syn.21950. Epub 2016 Nov 30.
- Results publication: PubMed 22863387Cooper O, Melmed S. Subclinical hyperfunctioning pituitary adenomas: the silent tumors. Best Pract Res Clin Endocrinol Metab. 2012 Aug;26(4):447-60. doi: 10.1016/j.beem.2012.01.002. Epub 2012 May 22.
- Results publication: PubMed 18780796Colao A, Di Somma C, Pivonello R, Faggiano A, Lombardi G, Savastano S. Medical therapy for clinically non-functioning pituitary adenomas. Endocr Relat Cancer. 2008 Dec;15(4):905-15. doi: 10.1677/ERC-08-0181. Epub 2008 Sep 9.
- Results publication: PubMed 21748460Su Z, Wang C, Wu J, Jiang X, Chen Y, Chen Y, Zheng W, Zhuge Q, Wu Z, Zeng Y. Expression of dopamine 2 receptor subtype mRNA in clinically nonfunctioning pituitary adenomas. Neurol Sci. 2012 Apr;33(2):275-9. doi: 10.1007/s10072-011-0701-6. Epub 2011 Jul 12.
- Individual participant dataSharing planned: No. The individual patient Data would not be shared to the third facility, but the sponsor hasn't decided whether to share the individual patient date to the other related studies hold by himself in the future.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Drug treatment and Surgery in people with Pituitary Adenoma, run by Zhebao Wu.
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 5 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: status not confirmed, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiting Gu, MD (0086-13917778956, nowaiting1221@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline on tumor volume (time frame: Up to 6 months]). 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 NCT03714763, which also lists 4 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 22 Oct 2018.