Neoplasms

All Conditions

Nervous System Diseases

Gland and Hormone Related Diseases

Adenoma

Pituitary Diseases

Pituitary Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Hypothalamic Diseases

Brain Diseases

Central Nervous System Diseases

Endocrine System Diseases

Endocrine Gland Neoplasms

Hypothalamic Neoplasms

Supratentorial Neoplasms

Brain Neoplasms

Central Nervous System Neoplasms

Nervous System Neoplasms

All Drugs and Chemicals

Cardiotonic Agents

Anti-Dyskinesia Agents

Hormones

Dopamine

Cabergoline

Bromocriptine

Dopamine Agonists

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

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

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.

Drug treatment

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

Surgery

Weiting Gu, MD

Zhebao Wu, Medical PhD

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）.

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.

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

The Predictive Value of Positron Emission Tomography-Magnetic Resonance (PET-MR) Mediated Dopamine D2 Receptors Imaging in the Drug Therapy of Nonfunctioning Pituitary Adenoma

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.

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.

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

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

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

Zhebao Wu

Principal Investigator

Antiparkinson Agents

Dopamine Agents

Neurotransmitter Agents

This group received cabergoline, in a total week dose of 3.5 mg, starting 6 months after transphenoidal surgical approach with evidence of tumoral rest in MRI and pituitary adenoma hystopathological confirmation.

This group was followed, with clinical visits in same frequency of study group, but without intervention.

Rafael L Batista, MD

Clinically nonfunctioning pituitary adenoma remains the only pituitary tumor subtype for which no effective medical therapy is available or recommended. We will evaluate the use of cabergoline in a clinical trial, in order to define the efficacy of this treatment in nonfunctioning pituitary adenoma.

Nonfunctioning pituitary adenomas (NFPA) are common tumors of sellar region characterized by the absence of clinically hormonal pituitary secretion. These adenomas are typically not diagnosed until they become very large and cause compressive neurologic symptons (e.g. visual impairment or cranial nerve palsy). Most of them are able to synthesized gonadotropins but not secreted it.

Transsphenoidal surgical resection is the first-choice therapy in NFPA. However, complete removal is difficult and tumor rest is very common. In these cases, the pragmatic use of radiotherapy is effective to reduce residual tumor growth or recurrence, but it is related with severe side effects. Another possibility is the clinical observation, or wait-to-see approach, but it is associated with tumor progression: 40% in 5-10 years. The efficacy of some medical treatment are not defined yet.

Since the identification of dopaminergic and somatostatinergic receptors in NFPA, the pharmacological treatment of the NFPA has been considered as a possibility for treatment. To date, clinical use of dopamine agonist (DA) in NFPA patients has been evaluated in some studies. However, these studies present modest and inconclusive results and the DA role in the NPFA management remains undefined.

In this study, the investigators plan a clinical trial designed to investigate the efficacy of cabergoline in NFPA individuals with remaining tumor after primary neurosurgery. These results could help to define the efficacy of DA in NFPA management.

A Single Center, Open Label and Randomized Clinical Trial.

Cabergoline in Nonfunctioning Pituitary Adenomas

Dopamine Agonist Cabergoline in Residual Clinically Nonfunctioning Pituitary Adenoma After Transphenoidal Surgery: A Single Center, Open Label and Randomized Clinical Trial

The protocol and statistical analysis plan will be disposable at researchgate site and by e-mail when it will be asked.

Absence of Cardiac Valvar Alterations with Cabergoline Use

no evidence of tumor growth with experimental therapy

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Dopamine D2 Receptors(D2R) Imaging in Nonfunctioning Pituitary Adenoma(NFPA)	NCT03714763	Pituitary Adeno...	Drug treatment Surgery	18 Years - 65 Years	Ruijin Hospital
Cabergoline in Nonfunctioning Pituitary Adenomas	NCT03271918	Pituitary Adeno... Nonfunctioning ...	Cabergoline	18 Years - 75 Years	University of Sao Paulo General Hospital

Spots Global Cancer Trial Database for nonfunctioning pituitary adenoma