Working… Menu
Trial record 28 of 38 for:    focused ultrasound | met

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01421407
Recruitment Status : Withdrawn
First Posted : August 22, 2011
Last Update Posted : May 6, 2014
Information provided by (Responsible Party):

Brief Summary:

Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease (CKD), including those who are undergoing long-term haemodialysis treatment. sHPT is characterized by persistently elevated levels of parathyroid hormone (PTH) and major disturbances in phosphorus and calcium metabolism. When glomerular filtration rate (GFR) falls, the phosphorus clearance decreases significantly, leading to phosphorus retention. The resulting hyperphosphatemia is thought to be one of the principal causes of secondary hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis and treatment is crucial in the management of such patients.The treatment of the sHPT of CKD's patient includes dietary phosphate restriction, the use of phosphate binders, correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic agent cinacalcet hydrochloride may be also used in combination with vitamin D. While the majority of patients can be controlled in this way, medical therapy is not always successful in achieving adequate control of secondary hyperparathyroidism. Oral medications (calcimimetics, recently developed phosphate binders, and active vitamin D derivatives amount to very high monthly costs, and have efficacy limitations as well as side-effects.

HIFU may become a valuable alternative treatment that help control secondary hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography,.

The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic haemodialysis patients with secondary hyperparathyroidism presenting with enlarged parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has been unsuccessful.

Condition or disease Intervention/treatment Phase
Secondary Hyperparathyroidism End Stage Renal Disease Parathyroid Hyperplasia Device: Ultrasonic ablation device Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Uncontrolled Secondary Hyperparathyroidism in Chronic Haemodialysis Patients
Study Start Date : August 2011
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Active Comparator: High Intensity Focused Ultrasound Device: Ultrasonic ablation device
High Intensity Focused Ultrasound treatment
Other Name: TH-One

No Intervention: Control group

Primary Outcome Measures :
  1. The proportion of patients with a reduction from baseline of at least 30% in mean serum iPTH levels at 6 months after the last HIFU session and continuation of optimal medical therapy. [ Time Frame: 6 months after the last HIFU session ]

Secondary Outcome Measures :
  1. Proportion of patients with a serum PTH in the KDIGO in the recommended range (approximately two to nine times the upper normal limit for the assay) [ Time Frame: at 6 months after last HIFU session ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Male or female patients 18 years or older with end stage renal disease (ESRD) on thrice-weekly stable haemodialysis since at least 3 months with biochemically uncontrolled secondary hyperparathyroidism.
  • PTH > 800 pg/ml with serum calcium > 8.4 mg/dl shown by three measurements obtained within a 30-day screening period, in spite of established maintenance dose for at least 3 months of Cinacalcet (>30mg/day) with or without vitamin D .
  • Patients who underwent subtotal parathyroidectomy or total parathyroidectomy without autotransplantation and have recurrent secondary hyperparathyroidism, are eligible provided that they meet all the other inclusion criteria and exclusion criteria.
  • Patients with one or two enlarged parathyroid glands, located with ultrasonography and with one or two over-active glands at sestamibi scintigraphy.

Exclusion Criteria:

  • Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
  • Serum total calcium (corrected for albumin) < 8.4 mg/dl (2.1 mmol/l)
  • Serum ionized calcium < 1 mmo/l.
  • Patient who underwent total parathyroidectomy with autotransplantation.
  • Known history of parathyroid or other neoplasias in the neck region.
  • History of neck irradiation
  • Patients with abnormal vocal cord mobility revealed by indirect laryngoscopy
  • Patients with enlarged parathyroid glands, not accessible to HIFU treatment.
  • Head and/or neck disease that prevents hyperextension of neck. - Major surgery or arterio-venous fistula clotting in the last 3 months or major surgery projected in the subsequent 4 months.
  • Pregnant or lactating woman.
  • Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
  • Patient receiving drugs such as flecainide, thioridazine, and most tricyclic antidepressants.
  • Patients who are currently participating in another clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01421407

Layout table for location information
Ospedale generale regionale "Miulli"
Acquaviva delle Fonti, Italy, 70021
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Milano, Italy, 20122
Hospital Universitario Marquès de Valdecilla
Santander, Cantabria, Spain, 39008
Sponsors and Collaborators
Layout table for investigator information
Principal Investigator: Angel Luis Martin DE FRANCISCO, Pr Hospital Universitario Valdecilla. Santander. Spain

Layout table for additonal information
Responsible Party: Theraclion Identifier: NCT01421407     History of Changes
Other Study ID Numbers: HIFU/E/HPT2/Jan2011
First Posted: August 22, 2011    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: May 2014
Keywords provided by Theraclion:
Secondary hyperparathyroidism
End stage renal disease
Parathyroid hyperplasia
High Intensity Focused Ultrasound
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism, Secondary
Neoplastic Processes
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Parathyroid Diseases
Endocrine System Diseases