ProlactinomaNCT03717454
Dopamine D2 Receptors(D2R) Imaging in Prolactinomas
A study testing Surgery and Drug treatment in people with Prolactinoma, run by Zhebao Wu.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Prolactinoma
- What is being tested?
- Surgery and Drug treatment
- 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 Dec 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
- Hyperprolactinemia;
- Enhanced pituitary MRI shows sella regional tumor;
- 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 or other drugs causing elevated PRL ;
- Patients with parkinson disease and is taking dopaminergic agents;
- Patients with prolactinoma who received Gamma knife treatment;
- Pregnant or lactating women, or women preparing pregnant;
- 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 of Prolactinomas.
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.
Read the detailed description
The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA 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 DA.
- Conditions
- Prolactinoma
- Being tested
- Surgery, Drug treatment
- Keywords
- Dopamine agonist, Dopamine D2 receptors, PET-MR
- Medical subject headings
- Prolactinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryOther
The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
Drug treatmentDrug
The medication will continue if DA causes tumors to shrink.
| Study group | Role | What they receive |
|---|---|---|
| Drug treatment | Experimental | Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume,visual acuity and visual field scale will be measured every 3 months.MRI showed that the tumors shrunk significantly. Receives: Drug: Drug treatment |
| Surgery | Experimental | Subjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The CAB or BC fail to decrease prolactinoma size. Receives: Other: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline on PRL level
Record the result of PRL on every 3 month follow-up visit
Measured: Up to 6 months
Secondary outcomes (3)
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 visits
Measured: Up to 6 months
Change from baseline of visual field scale
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
Change from baseline of visual acuity
Record the Visual acuity on every 3 month follow-up visit.
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 posted24 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion30 Dec 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 (3)Papers the sponsor has linked to this study.
- Other trials for ProlactinomaStudies 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
- NCT03717454
- Sponsor's protocol ID
- DD2RP-2018
- Status last verified
- Nov 2018
- First submitted
- 14 Oct 2018
- Last updated
- 20 Nov 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 27864853Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, Wass JA; Endocrine Society. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Feb;96(2):273-88. doi: 10.1210/jc.2010-1692.
PubMed 21296991Schonitzer V, Haasters F, Kasbauer S, Ulrich V, Mille E, Gildehaus FJ, Carlsen J, Pape M, Beck R, Delker A, Boning G, Mutschler W, Bocker W, Schieker M, Bartenstein P. In vivo mesenchymal stem cell tracking with PET using the dopamine type 2 receptor and 18F-fallypride. J Nucl Med. 2014 Aug;55(8):1342-7. doi: 10.2967/jnumed.113.134775. Epub 2014 Jul 14.
PubMed 25024426
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 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 of Prolactinomas.
- ClinicalTrials.gov ID
- NCT03717454
- Acronym / sponsor ID
- DD2RP-2018
- Conditions
- Prolactinoma
- Keywords
- 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 Dec 2018 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 24 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 prolactinoma and the predictive role of dopamine D2 receptors PET-MR imaging in the therapeutic effect of dopamine agonists.
Detailed description
The dopamine agonist(DA),such as cabergoline(CAB) and bromocriptine(BC), has been used widely in the treatment of prolactinomas, but its clinical use is hampered by intolerance and/or resistant in some patients. It had been showed that DA 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 DA.
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 are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume,visual acuity and visual field scale will be measured every 3 months.MRI showed that the tumors shrunk significantly. |
| Surgery | Experimental | Other: SurgerySubjects are treated with CAB tablets 2mg/week or BC tablets 7.5mg/day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The CAB or BC fail to decrease prolactinoma size. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hyperprolactinemia;
- Enhanced pituitary MRI shows sella regional tumor;
- 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 or other drugs causing elevated PRL ;
- Patients with parkinson disease and is taking dopaminergic agents;
- Patients with prolactinoma who received Gamma knife treatment;
- Pregnant or lactating women, or women preparing pregnant;
- 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 |
|---|---|---|
| SurgeryThe medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery . | Other | Surgery |
| Drug treatmentThe medication will continue if DA causes tumors to shrink. | Drug | Drug treatment |
Primary outcome
Change from baseline on PRL level
Time frame: Up to 6 months
Record the result of PRL on every 3 month follow-up visit
3 secondary outcomes
Change from baseline on tumor volume measured by enhanced pituitary Magnetic Resonance Imaging（MRI）
Time frame: Up to 6 months
Change from baseline of visual field scale
Time frame: Up to 6 months
Change from baseline of visual acuity
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 20 Nov 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 21296991Melmed S, Casanueva FF, Hoffman AR, Kleinberg DL, Montori VM, Schlechte JA, Wass JA; Endocrine Society. Diagnosis and treatment of hyperprolactinemia: an Endocrine Society clinical practice guideline. J Clin Endocrinol Metab. 2011 Feb;96(2):273-88. doi: 10.1210/jc.2010-1692.
- Results publication: PubMed 25024426Schonitzer V, Haasters F, Kasbauer S, Ulrich V, Mille E, Gildehaus FJ, Carlsen J, Pape M, Beck R, Delker A, Boning G, Mutschler W, Bocker W, Schieker M, Bartenstein P. In vivo mesenchymal stem cell tracking with PET using the dopamine type 2 receptor and 18F-fallypride. J Nucl Med. 2014 Aug;55(8):1342-7. doi: 10.2967/jnumed.113.134775. Epub 2014 Jul 14.
- 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.
Related trials for Prolactinoma
RecruitingObservational study
An Investigation of Pituitary Tumors and Related Hypothalmic Disorders
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Active, not recruitingObservational study
Long Term Outcome Study in Patients With Pituitary Disorders
Pituitary Diseases, Pituitary Neoplasms
RecruitingPhase 3
Safety and Potency of a High Cabergoline Dosage in Microprolactinomas
Prolactinoma, Prolactin Excess
RecruitingPhase 2
A Study of Pasireotide in People With Prolactinoma
Prolactin-Producing Pituitary Tumor
Active, not recruitingObservational study
The PROMISE Survey
Prolactinoma, Pituitary Tumor
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 Surgery and Drug treatment in people with Prolactinoma, 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 20 Nov 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 PRL level (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 NCT03717454, which also lists 3 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 20 Nov 2018.