CClinicalTrials.gg
Status unknownNCT03714763Updated Oct 22, 2018

Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)

An interventional study of Drug treatment and Surgery in Pituitary Adenoma, sponsored by Zhebao Wu. Status unknown. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-22.

Sponsored by Zhebao Wu · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Pituitary Adenoma

Keywords

  • Nonfunctioning Pituitary Adenoma
  • Dopamine Agonist
  • Dopamine D2 Receptors
  • PET-MR
03

In context

Adenoma

657 studies on the registry are indexed under Adenoma; 98 are open to participants now.

This study's planned enrollment of 50 is below the median of 250 across 412 interventional studies indexed under Adenoma.

Browse Adenoma studies →

Lead sponsor

Zhebao Wu is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Normal serum pituitary hormone levels or mild increase of serum prolactin.
  2. Enhanced MRI shows a pituitary tumor and tumor diameter>1cm.
  3. Aged between 18 and 65 years old, either sex.
  4. Karnofsky performance status ≥ 70.
  5. The patient has signed the informed consent.

Exclusion criteria

Exclusion Criteria:

  1. Patients concomitantly taking the psychotropic drugs.
  2. Patients with parkinson disease and is taking dopaminergic agents.
  3. Patients with pituitary adenoma who received Gamma knife treatment.
  4. Pregnant or lactating women.
  5. Patients with poor compliance, who cannot implement the program strictly.
  6. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cabergoline.
  7. Patients with claustrophobia. -
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    Drug treatment

    Subjects who show high expression of dopamine D2 receptors in PET-MR imaging.

    Drug: Drug treatment

  • Experimental
    Surgery

    Subjects who show low expression of dopamine D2 receptors in PET-MR imaging.

    Other: Surgery

Interventions

  • DrugDrug treatment

    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.

  • OtherSurgery

    Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to 6 months]

Secondary outcomes

  1. Change from baseline of visual acuity

    Record the Visual acuity on every 3 month follow-up visit.

    Time frame: Up to 6 months

  2. 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

    Time frame: Up to 6 months

07

Study locations

No study locations are listed for this record.

08

References and documents

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 27864853 ↗
  • Cooper 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 22863387 ↗
  • Colao 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 18780796 ↗
  • Su 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 ↗

Individual participant data

Plan to share: 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.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03714763
Lead sponsor
Zhebao Wu
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
Zhebao Wu (Principal Investigator, Ruijin Hospital) — Sponsor-investigator
First posted
Oct 22, 2018
Start date
Nov 1, 2018 (estimated)
Primary completion
Nov 30, 2021 (estimated)
Completion
Jan 31, 2022 (estimated)
Last update
Oct 22, 2018

Study contacts

Weiting Gu, MD
Contact
nowaiting1221@hotmail.com
0086-13917778956
Zhebao Wu, Medical PhD
Contact
zhebaowu@aliyun.com
0086-021-64370045

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion