Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Carmel Medical Center
Sponsor:
Information provided by (Responsible Party):
Carmel Medical Center
ClinicalTrials.gov Identifier:
NCT01699347
First received: August 19, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

Cohort study evaluate the efficacy treatment with OK-432 in cystic malformation of the head and neck region.

The malformations are macrocystic and the preevaluation will include CT/MRI, US and blood tests.

The injection will be in the OR under US guided, maximal dose will be 0.2mg. The follow-up will be of short term - till 30 days post injection and long term - follow-up wil be till 2 years.


Condition Intervention Phase
CYSTIC MALFORMATION
Drug: Intracystic injection of OK432 under US guiding
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cohort Prospective Study of Children With Head and Neck Cystic Malformation Who Are Treated With Intracystic OK432

Further study details as provided by Carmel Medical Center:

Primary Outcome Measures:
  • evaluation of the efficacy in treating cystic malformation with OK432 by measuring time that elapsed without recurrence [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • TREATMENT SAFETY BY no. of participants with adverse events [ Time Frame: 4 YEARS ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 5
Study Start Date: September 2012
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OK432
Intracystic injection of OK432 under US guiding
Drug: Intracystic injection of OK432 under US guiding
Intracystic injection of OK432 under US guiding
Other Name: OK432 (Picibanil)

Detailed Description:

A cohort study, before the injection all the patients in the study will go through:

  1. CT/MRI
  2. US to estimate the cyst size
  3. CBC, PT, PTT, INR, ASLO
  4. ECG If the patient is qualified to the study the parent will sign on the inform consent, than the child will be photographed AP and lateral.

The injection will be held in the OR under US guidance with 18q20 gauge needle, first all the cyst contents will be sucked than the OK432 will be injected in.

After the injection the child will stay for one night if it was general anesthesia and 4 hours in the case of local anesthesia.

Short term follow - 3-5 days with the phone, up: till 30 days from the injection with US, stills photo.

Long term follow-up: 6 months, 1 year, 2 years

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • LYMPHATIC MALFORMATION MACROCYSTIC OR MIXED WITH MORE THEN 50% MACROCYSTIC.
  • ONLY IN THE HEAD AND NECK AREA
  • TIME FROM OPERATION AT LEAST 6 MONTHS

Exclusion Criteria:

  • penicillin allergy
  • pregnancy
  • familial history of RF
  • Post streptococcal glomerulonephritis
  • Background illness-heart, kidney, lungs
  • fever > 38.5c in the op day
  • URT Infection
  • Family history of PANDAS
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01699347

Locations
Israel
Department of Otolaryngology, Carmel Medical Center Recruiting
Haifa, Israel, 34362
Contact: Raanan Cohen-Kerem, MD    +97248250279    raanan@clalit.org.il   
Principal Investigator: Raanan Cohen-Kerem, MD         
Sponsors and Collaborators
Carmel Medical Center
Investigators
Principal Investigator: Raanan Cohen-Kerem, MD Carmel Medical Center, Haifa, Israel
  More Information

No publications provided

Responsible Party: Carmel Medical Center
ClinicalTrials.gov Identifier: NCT01699347     History of Changes
Other Study ID Numbers: CMC-11-0059-CTIL
Study First Received: August 19, 2012
Last Updated: November 28, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Carmel Medical Center:
OK432, CYSTIC MALFORMATION

Additional relevant MeSH terms:
Congenital Abnormalities
Picibanil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014