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

Sponsor
Zhebao Wu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03714763
Collaborator
Xinqiao Hospital of Chongqing (Other), First Hospital of China Medical University (Other), Beijing Tiantan Hospital (Other), First Affiliated Hospital of Wenzhou Medical University (Other), First Affiliated Hospital of Fujian Medical University (Other), Peking Union Medical College Hospital (Other), Huashan Hospital (Other), Chinese PLA General Hospital (Other)
50
2
39

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Drug treatment
  • Other: Surgery
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Nov 1, 2018
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Drug treatment

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

Drug: Drug 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.

Experimental: Surgery

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

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

Outcome Measures

Primary Outcome Measures

  1. Change from baseline on tumor volume [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.

Secondary Outcome Measures

  1. Change from baseline of visual acuity [Up to 6 months]

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

  2. Change from visual field scale [Up to 6 months]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
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:
  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. -

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Zhebao Wu
  • 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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhebao Wu, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT03714763
Other Study ID Numbers:
  • DD2RN-2018
First Posted:
Oct 22, 2018
Last Update Posted:
Oct 22, 2018
Last Verified:
Oct 1, 2018
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Zhebao Wu, Principal Investigator, Ruijin Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 22, 2018