Please select the eligibility criteria that correspond to the clinical trial below.
Title: Phase IIIb, Multicentre, Open-label, Single-arm, Study to Assess the Efficacy and Safety of Lanreotide Autogel 120 mg Administered Every 28 Days as Primary Medical Treatment in Acromegalic Patients With Macroadenoma
Brief Summary: Acromegaly is a chronic disease caused by excessive secretion of growth hormone (GH) and mainly due to benign tumour localized in the pituitary gland.

The disease develops insidiously, causing a gradual progression of symptoms; consequently most patients are diagnosed in their fourth decade of life.

Administration of somatostatin analogues such as lanreotide have been shown to result in normalisation or the decrease of GH and insulin growth factor (IGF-1) levels and improvement of clinical symptoms in acromegalic patients. The purpose of this study is to evaluate whether lanreotide is also effective on tumour volume reduction (tumour shrinkage) and the benefits of this potential tumour shrinkage on disease symptoms and patient's quality of life.


Options:
A: Inclusion Criteria:

* The patient has given written informed consent prior to any study related procedures
* The patient is male or female and is aged between 18 and 75 years, inclusive,
* Diagnosis of acromegaly defined by i) GH nadir \> 1 ng/mL as assessed by an oral glucose tolerance test for non diabetic patients (central laboratory results) or a mean GH level \> 1 ng/mL based on 5 samples taken every 10 to 15 minutes for diabetic patients ( central laboratory results) AND ii) IGF-1 concentrations elevated above the age- and sex-matched normal range for diabetic and non diabetic patients (central laboratory results),
* The patient has a pituitary adenoma with a diameter greater than or equal to 10 mm based on Magnetic Resonance Imaging (MRI) central reading,
* The patient has no visual field defect identified at the visual evaluation, performed by Goldman Visual Fields Analyser and Automated visual field static perimeter, except visual field abnormality at the time of screening and that is in the investigator's Clinical judgement:

  * Not related to the pituitary adenoma
  * Clinically stable condition not presumed to change during the study period
  * Not modifying the ability to evaluate visual field changes related to the macroadenoma

Exclusion Criteria:

* The patient has a history of hypersensitivity to Lanreotide or drugs with a similar chemical structure,
* The patient has received any unlicensed drug within the 30 days prior to the screening visit or is scheduled to receive an unlicensed drug during the course of the study,
* The patient is likely to require treatment during the study with somatostatin analogues other than Lanreotide Autogel 120 mg, dopamine agonist, GH receptor antagonist (pegvisomant), and Cyclosporine or drugs that are not permitted by the study protocol,
* The patient is a female at risk of pregnancy during the study and is not using acceptable contraceptive methods. Females of childbearing potential must provide a negative pregnancy test at start of study and must be using oral, double barrier (condom with spermicidal jelly, foam suppository, or film; diaphragm with spermicide; or male condom and diaphragm with spermicide), injectable contraception or an intra uterine device. Non childbearing potential is defined as post-menopause for at least 1 year, surgical sterilisation or hysterectomy at least three months before the start of the study,
* The patient is pregnant or lactating,
* The patient has a history of, or known current, problems with alcohol abuse,
* The patient has any mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study, and/or evidence of an uncooperative attitude.
* The patient has abnormal baseline findings, any other medical condition(s) or laboratory findings that, in the opinion of the Investigator, might jeopardize the patient's safety or decrease the chance of obtaining satisfactory data needed to achieve the objective(s) of the study,
* The patient has undergone pituitary surgery or pituitary radiotherapy prior to study entry,
* The patient has previously been treated with a somatostatin analogue,
* The patient has received a dopamine agonist or a GH receptor antagonist (pegvisomant) prior to study entry,
* The patient is expected to require pituitary surgery (adenomectomy) or to receive radiotherapy during the study period,
* Patients with suspected associated prolactinoma: prolactin level \> 100 ng/mL (central laboratory results),
* Patient is allergic to Gadolinium (MRI contrast agent) or has acute or chronic severe renal insufficiency (glomerular filtration rate \<30 mL/min/1.73m2),
* Patient known by Investigator, to have congenital or acquired optic nerve disease or any visual abnormality with risk of worsening during the course of the study (e.g glaucoma), influencing ability to evaluate Visual Field changes related to the macroadenoma.
B: Inclusion Criteria:

* patients with newly diagnosed acromegaly due to GH-secreting macro-adenomas.
* newly diagnosed, previously untreated patients with GH nadir more than 2.5 μg/L during a standard 75-g, 2-h oral glucose tolerance test (OGTT)
* pituitary macroadenomas (maximum diameter \>1 cm) verified by a pituitary magnetic resonance imaging (MRI) scan
* age between 18 and 80 yr.

Exclusion Criteria:

* immediate surgery indicated by clinical criteria
* pregnancy
* contraindications to MRI scan
* patients judged not suitable to participate in the study for other reasons such as personality disorders and alcohol abuse.
C: Inclusion Criteria:

Acromegaly:

* Male or female patients ≥18 years of age
* Acromegaly currently treated with Sandostatin LAR

NET:

* Male or female patients ≥18 years of age
* Functional, well-differentiated (Grade 1 or Grade 2) NET with symptoms of carcinoid syndrome (number of bowel movements and/or flushing)
* Currently treated with Sandostatin LAR for symptom control

Exclusion Criteria:

Acromegaly:

* Inadequate bone marrow function
* Abnormal coagulation or chronic treatment with warfarin or coumarin derivates
* Impaired liver, cardiac and/or renal function
* Known gallbladder, bile duct disease or pancreatitis
* Diabetes with poorly controlled blood glucose levels despite adequate therapy
* Hypothyroidisms not adequately treated

NET:

* Poorly differentiated neuroendocrine carcinoma, high-grade neuroendocrine carcinoma, adenocarcinoid, pancreatic islet cell carcinoma, insulinoma, glucagonoma, gastrinoma, goblet cell carcinoid, typical and atypical lung carcinoids, large cell neuroendocrine carcinoma and small cell carcinoma
* Carcinoid syndrome refractory to treatment with conventional doses of somatostatin analogues (SSAs)
* Inadequate bone marrow function
* Abnormal coagulation or chronic treatment with warfarin or coumarin derivates
* Impaired liver, cardiac and/or renal function
* Known gallbladder, bile duct disease or pancreatitis
* Short-bowel syndrome
* Diabetics with poorly controlled blood glucose levels despite adequate therapy
* Hypothyroidism, not adequately treated
D: Inclusion Criteria:

* Patients with active acromegaly due to a pituitary adenoma
* Patients who have been previously treated for acromegaly with certain medications may be required to be without certain medications prior to entering the study

Exclusion Criteria:

* Patients with compression of the optic chiasm causing any visual field defect
* Patients who require a surgical intervention for relief of any sign or symptom associated with tumor compression
* Patients who have received radiotherapy in the 2 years prior to the start of the trial
* Patients who have congestive heart failure, unstable angina, cardia arrhythmia, or a history of acute myocardial infarction within the three months preceding enrollment
* Patients with gallstone disease
* Patients with chronic liver disease
* Known hypersensitivity to Sandostatin or Sandostatin LAR
* Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control and highly effective method for birth control
* History of immunocompromise, including a positive HIV test result
* Patients who have a history of alcohol or drug abuse in the six-month period prior to the enrollment visit
* Patients who have participated in any clinical investigation with an investigational drug within 4 weeks prior to dosing

Answer: A