Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT00325104
Eligibility Criteria:
* INCLUSION CRITERIA:
Criteria for inclusion
1. Patients with primary hyperparathyroidism associated with MEN1 or 2A syndrome and no indications for current surgical interventions.
2. For initial pilot study, 15-20 patients with MEN1 syndrome and biochemical evidence of hyperparathyroidism will be included.
3. For initial pilot study, 5-10 patients with MEN2A syndrome and biochemical evidence of hyperparathyroidism will be included. Each MEN2A case must have residual MTC tumor.
4. In case of ZES, good acidity control with proton pump inhibitors (PPI), documented by basal acid output (BAO) of less than 10 mEq/h.
5. Willingness and legal ability to give informed consent.
6. MEN1, like MEN2A has a normal gender and ethnic distribution. These will be maintained, within the limits of a small number of subjects studied.
EXCLUSION CRITERIA:
Criteria for exclusion or removal
1. Age less than 18 years
2. Pregnancy
3. Creatinine greater than 1.4
4. SGOT or SGPT greater than twice normal
5. Indications for current surgery:
1. Hyperparathyroidism
* Albumin-adjusted serum calcium level higher than 3.0 mmol/L (12.0 mg/dL)
* Kidney stones
* Significant PTH-induced bone disease
* Age below 50 is not considered as absolute indication for parathyroid surgery herein
2. Enteropancreatic neuroendocrine neoplasia
* Single lesion meeting criteria for surgery
* Need for debulking surgery for obstructive or other complications
* Acute abdominal complications of any kind
* Inability of control on PPI in case of ZES
6. Chemotherapy within last 6 months
7. Lactating females
8. Patients with contraindications for MRI study, including pacemakers, vascular clips, implants, foreign bodies etc., as per NIH-MRI Safety Guideline.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00325104
Study Brief:
Protocol Section:
NCT00325104